BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2001223 · Received February 24, 2011

    Report

    Report Number
    2015691-2011-14879
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    October 18, 2010
    Report Date
    January 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE REASON FOR EXPLANTING THE DEVICE WAS DUE TO A SIZING ISSUE; THERE WAS A JET AFTER GOING OFF BYPASS. ACCORDING TO THE OPERATIVE REPORT: "THE AORTA WAS OPENED TRANSVERSELY. THE AORTIC VALVE WAS INSPECTED. I DECIDED TO REPLACE IT. AORTIC VALVE WAS EXCISED. A DÉBRIDEMENT WAS PERFORMED OF THE ANNULUS. CALCIUM EXTENDED OUT TO THE MITRAL VALVE LEAFLET. THIS WAS ALL DEBRIDED. THE ANNULUS WAS SIZED. A 23MM BOVINE PERICARDIAL VALVE WAS SELECTED. THE VALVE WAS LOWERED INTO POSITION AND THE SUTURES WERE TIED. THE VALVE SEEMED TO SEAT WELL. THE AORTOTOMY WAS CLOSED, DE-AIRING PROCEDURE WAS CARRIED OUT. THE CROSSCLAMP WAS RELEASED. THERE WAS A JET OF AORTIC INSUFFICIENCY. THIS WAS INSIDE THE SEWING RING. IT WAS UNCLEAR WHAT THE ETIOLOGY OF THIS WAS. THIS SEEMED TO BE AT LEAST 1+, HOWEVER. I THOUGHT WE WOULD NEED TO INSPECT THE VALVE TO SEE WHAT THE PROBLEM WAS. WE WENT BACK ON BYPASS. THE AORTOTOMY WAS OPENED. THE VALVE WAS INSPECTED. I DID NOT SEE ANY OBVIOUS DEFECTS IN THE VALVE LEAFLETS. I WONDERED IF PERHAPS THERE WAS SOME TYPE OF DEFECT IN THE VALVE ITSELF. THE VALVE WAS REMOVED. THE ANNULUS WAS SIZED AGAIN. I DECIDED TO PLACE ON SIZE LARGER VALVE (EDWARDS VALVE). SUTURES WERE PLACED AROUND THE ANNULUS AGAIN. THE SUTURES WERE PLACED THROUGH THE SEWING RING OF THE VALVE. VALVE WAS LOWERED INTO POSITION AND SUTURES WERE TIED. AGAIN, THE VALVE SEEMED TO SEAT WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-10E1351

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention