BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1994207 · Received February 16, 2011

    Report

    Report Number
    2015691-2011-14805
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    October 5, 2010
    Report Date
    January 5, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THROUGH FOLLOW UP IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO SIZING AND A LARGER RING SIZE WAS IMPLANTED (SIZE 38MM). ACCORDING TO THE OPERATIVE REPORT, "INITIALLY THE ANNULOPLASTY WAS PERFORMED WITH A 34MM ANNULOPLASTY BAND. HOWEVER, A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED EVIDENCE FOR INTERMITTENT SAM. IT IS DECIDED TO REVISE THE ANNULOPLASTY TO A LARGER SIZE; A 38MM SIZE WAS CHOSEN." PER THE SURGEON, THE REASON FOR EXPLANTING THE DEVICE WAS PROCEDURE RELATED AND NOT DUE TO A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R-10H2125

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention