BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1960630 · Received January 13, 2011

    Report

    Report Number
    2015691-2011-14672
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    September 27, 2010
    Report Date
    December 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LEFT MAIN OBSTRUCTION. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO THE OBSTRUCTION OF THE LEFT MAIN. ACCORDING TO THE OPERATIVE REPORT, AFTER THE VALVE WAS PLACED, IT WAS NOTED THAT THE PATIENT'S LEFT MAIN WAS SHIFTED TOWARD HER LEFT COMING OFF NEAR THE LEFT-RIGHT COMMISSURE. EFFLUENT WAS SEEN COMING FROM THE LEFT MAIN WHEN RETROGRADE WAS GIVEN. ONCE OFF BYPASS, IT WAS IMMEDIATELY NOTED THAT THE PATIENT'S LV FUNCTION WAS DIMINISHED, AND SHE HAD WIDENED QRS, AND FLOW WAS DOCUMENTED WITH THE LEFT MAIN, BUT IT DID APPEAR ABNORMAL AND SLUGGISH. IT WAS FELT THAT THE PATIENT WAS AT HIGH RISK FOR A LEFT MAIN OBSTRUCTION DUE TO THE POSITION OF HER CORONARIES AND THE FACT THAT SHE HAD A POST NEAR THE LEFT MAIN. THEREFORE, THE VALVE WAS REMOVED AND IT WAS NOTED THAT THE LEFT MAIN APPEARED INTACT WITHOUT COMPROMISE; HOWEVER, IMPRINT OF THE POST WAS NEAR THE LEFT MAIN, WHICH MAY HAVE IMPEDED FLOW. ACCORDING TO THE HEALTH-CARE PROVIDER, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. 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 AT IMPLANT. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 R-09M2880

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention