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    Posted October 6, 2013 by
    Chicago, Illinois
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    FDA Cover-up The Smoking Gun: The Design History File



    Proof for the need for Informed Consent

    In 2008, after Northwestern University removed my access to the patients who received the experimental prototypes of the Myxo ETlogix model 5100, I discovered the MAUDE database. The database became my only access to information regarding the patients who received model 5100, and the other predicate devices justified in the design history file for Edwards LifeSciences Annuloplasty rings.
    MAUDE stands for manufacturer and user facility device experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative-reporting requirements granted under 21 CFR 803.19.
    An on-line search is available which allows an individual to search the Center Device Radiologic Health, CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties. MAUDE data is not intended to be used to either evaluate rates of adverse events or to compare adverse event occurrence rates across devices.
    The FDA does use the data to determine if there are an unusual large number of events. Section 522 of the Federal Food, Drug and Cosmetic Act (the act) gives FDA authority to require a manufacturer to conduct post-market surveillance of a class II or class III device that meets the following criteria: failure of the device would reasonably be likely to have serious adverse health consequences(
    Edwards Lifesciences annuloplasty rings have several adverse events reported in the MAUDE database. I started to follow the trend, which was increasing exponentially in 2010. By the end of the year, the number of events was over 4,000 in total and of those events, 645 are deaths. I have reported these events to the head of the FDA CDRH Dr. Jeffrey Shuren in 2010. In email communications to myself, Dr. Shuren requested by email my analysis of the situation.
    Coincidently, the trend increased significantly after Edwards Lifesciences received the March 1, 2010 warning letter for lack of adverse event reporting (See Myxo Files Part I-V). These events are all related to the devices that are cleared under the 510(k) clearance process, and the design history file as outlined in the Myxo File Part VII.
    The concept of a manufacturer clearing a device using the 510(k) or the design history file, fall under the terminology coined as “predicate creep”. In 2012, Public Citizen published on their website a document reviewing the 510(k) process and the 1997 FDA guidance document. They entitled the analysis: Substantially Unsafe: (

    Predicate devices that are justified in the design history file, require multiple levels of design controls as published in the Design History File, The Myxo File Part VII. As of August 3 2013, the number of annuloplasty rings listed as substantially equivalent by Edwards Lifesciences FDA registry is 6 in total. K020864, Edwards MC Tricuspid Annuloplasty system model 4900, K032250, Geoform annuloplasty ring Model 4200, K083191 DETlogix annuloplasty model 5100, K083470 Carpentier-Edwards Physio II annuloplasty model 5200, K083623 Carpentier-McCarthy-Adams IMR ETLogix Annuloplasty ring model 4100, and K103520 Carpentier-Edwards Physio Tricuspid Annuloplasty Model 6200.

    Edwards Lifesciences sells 8 total annuloplasty rings currently on the US website.

    The design history file as defined in the Myxo File Part VII, allows the manufacturer to evolve the next generation of devices and justify that any modification compare the new device to the predicate device as substantially equivalent. This concept is also entitled predicate creep, allowing only the manufacturer to decide whether or not the modifications are only minor changes as compared to the next generation, and to the next generation device etc. The only caveat to this approach, is that the manufacturer register and list the device as outlined in the Myxo File Part VII. This allows the FDA to perform any necessary post-market surveillance to identify any potential design flaws.

    The chief of cardiac surgery at Northwestern University, Dr. Patrick McCarthy, stated in the publication of the study, that the model 5100 was the first in use human testing. The data was necessary prior to the launch on the US market to validate the new patent pending design, and to obtain the internal FDA approval by the device manufacturer. As outlined in the previous Myxo Files, my patient reported to me in April 2007, that she had not signed an informed consent to receive the device during her surgery in April 2006, as soon as she was diagnosed as needing a second heart surgery. I immediately reported this fact to my supervisor Dr. Robert Bonow, the chief of cardiology at that time and senior author of the study. I removed my participation from the study in hopes that the patients would be informed of the experimental nature of the study. I then reported to NMFF general counsel who assured me that they would take care of the situation.

    Since 2007 I have accumulated several lines of evidence that indeed the device was a prototype, part of the validation testing necessary for the design controls in the design history file, and the results of the study were necessary for the patent, the eventual 510(k) clearance, and the design history file justification. Appropriately, once the validation results were completed, Edwards Lifesciences reported to the SEC and investors that the launch of the new Myxo ETlogix model 5100 was on sale in the US market in the first quarter of 2007.

    There are several lines of evidence to demonstrate that Edwards Lifesciences was performing a validation test prior to the official sales on the US market. The informed consent provided to the patients is insufficient under Title 21 and the Common Rule under HHS. The inventor, the company, and the hospital are required under the laws which protect human subjects to inform the patients of the validation studies performed the Design History File located at Edwards LifeSciences(Irvine, CA).

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