BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2092059 · Received May 18, 2011

    Report

    Report Number
    2015691-2011-15561
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THAT THIS EXPLANT WAS DUE TO PATIENT OR PROCEDURE RELATED ISSUES. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AND NO OPERATIVE REPORT HAS BEEN PROVIDED. THERE ARE SEVERAL REASONS WHY A VALVE IS EXPLANTED AT IMPLANT. THIS IS TYPICALLY THE RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. WITHOUT THE ADDITIONAL EVENT INFORMATION OR RETURN OF THE DEVICE FOR EVALUATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE FOR EXPLANT OF THIS DEVICE.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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, A VALVE WAS EXPLANTED AT IMPLANT. A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING "I PUT THE PERIMOUNT VALVE IN FIRST AND AS IT LEAKED SEVERELY ON TOE I HAD NO OPTION BUT TO RE-CLAMP AND REPLACE IT WITH AN SAV VALVE. IT WAS A DIFFICULT IMPLANT FOR A NUMBER OF REASONS BUT THE VALVE SEEMED TO SIT WELL ON THE ANNULUS WITH ALL 3 STENT POSTS IN THE VENTRICLE. I TOOK THE VALVE OUT AND COULD SEE NOTHING WRONG WITH IT. IT MAY HAVE BEEN DISTORTED DUE TO A HUGE PAPILLARY MUSCLE WHICH WOULD BE AN IMPLANT ISSUE NOT A STRUCTURAL VALVE ISSUE. I THOUGHT IT BEST JUST TO CHANGE IT RATHER THAN RE-USE IT. ONCE AGAIN I DO NOT FEEL IT WAS IN ANY WAY DEVICE RELATED RATHER A DIFFICULT IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 10L238

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R