BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2853356 · Received November 30, 2012

    Report

    Report Number
    2015691-2012-18734
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE HAS BEEN ARRANGED FOR RETURN AND EVALUATION, BUT HAS NOT YET BEEN RECEIVED BY EDWARDS. THEREFORE, THE REPORTED THICKENING AND CALCIFICATION OF THE BIOPROSTHESIS CANNOT BE CONFIRMED. ADDITIONAL INFORMATION AND EDWARDS CONCLUSIONS WILL BE REPORTED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA EDWARDS SALES THAT A 3000TFX 23 MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 5 YEARS DUE TO REGURGITATION. ADDITIONAL PATIENT HISTORY: "PATIENT WAS DIAGNOSED WITH NON-HODGKIN'S LYMPHOMA AND RECEIVED BOTH CHEMO THERAPY AND RADIATION. HOWEVER, THE IMPLANTING SURGEON DID NOT FEEL THE VALVES WAS IN DIRECT CONTACT WITH RADIATION. THE SURGEON DID IMPLANT ANOTHER 23 MM 3000TFX AFTER ATTEMPTING TO PLACE AN EW SA PORCINE VALVE THAT WAS TO BIG FOR THE ROOT. TEE DONE ON (B)(6) 2012, INDICATE THE RIGHT CORONARY CUSP APPEARS CALCIFIC WITH RESTRICTED MOTION. SEVERE AORTIC REGURGITATION NOTED WITH PERI VALVULAR LEAK. ECHO DONE ON (B)(6) 2012 (PRE OP) INDICATES 23 MM WELL SEATED BIOPROSTHETIC AORTIC VALVE, THICKENED LEAFLETS, ANTERIOR LEAFLET IS THICKENED AND RIGID. IT IS WELL SEATED. SEVERE AORTIC REGURGITATION. OPERATIVE REPORT INDICATES THE VALVE WAS REPLACED WITH ANOTHER PERICARDIAL BIOPROSTHESIS. ALSO NOTED BY THE SURGEON IN THE OPERATIVE REPORT, "THIS PROCEDURE WAS EXTREMELY DIFFICULT BECAUSE OF THE INABILITY TO PLACE A PORCINE VALVE, DESPITE AN AORTOPLASTY, AND THE PROFOUND BLEEDING AT THE SUTURE LINES WHICH TOOK SEVERAL HOURS TO CONTROL. THIS ADDED 60% EXTRA TIME TO THE PROCEDURE. THIS PATIENT SHOULD NOT HAVE CARDIAC SURGERY AGAIN".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR VENLAFAXINE| LORAZEPAM 0.5 MG| CRESTOR40 MG| COUMADIN 5 MG