BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2060336 · Received April 15, 2011

    Report

    Report Number
    2015691-2011-15246
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, A SLIGHT GAP IS NOTED AT THE COAPTATION REGION. A CUT IS DETECTED IN THE SEWING RING. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. THE VALVE WAS SENT TO R&D FOR FUNCTIONAL TESTING. ON (B)(6) 2011, THE DEVICE WAS DISMANTLED FOR THE SERIAL NUMBER. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. R&D CONCLUDED WITH THE FOLLOWING: " THIS VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 0.7 MONTHS DUE TO AORTIC REGURGITATION. IT WAS REPORTED THAT SEVERE CALCIFICATION WAS OBSERVED ON THE PATIENT'S NATIVE VALVE AND ANNULUS. AN INDEPENDENT ECHOCARDIOGRAPHY EVALUATION FOUND "MILD CENTRAL VALVULAR REGURGITATION" AND "MODERATE PARAVALVULAR AORTIC REGURGITATION". THE EVALUATION FURTHER STATES THAT "ANNULAR CALCIFICATION RAISES THE POSSIBILITY OF IMPERFECT VALVE SEATING RESPONSIBLE FOR THE PARAVALVULAR JET". EDWARDS' STANDARDIZED IN VITRO TESTING CONFIRMED THE "MILD" CENTRAL REGURGITATION BY THE PRESENCE OF A VERY SMALL CENTRAL HOLE AND A SMALL AMOUNT OF LEAKAGE (TRF OF 3.8%). THIS VALUE IS MORE THAN TWO TIMES LOWER THAN THE 10% ALLOWABLE FOR THIS SIZE VALVE PER (B)(4). THESE DATA FROM THE IN VITRO TESTING ARE CONSISTENT WITH THE INDEPENDENT ECHOCARDIOGRAPHY EVALUATION." METHOD: X-RAY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: NO DHR CAN BE DONE AS THE SERIAL NUMBER WAS NOT REPORTED. CUSTOMER REQUESTED US TO EVALUATE IF THERE WAS ANY STENT DISTORTION OR INCOMPLETE COAPTATION. (B)(6) 2011 ECHO DVD WAS RECEIVED AND WAS FORWARDED TO AN INDEPENDENT CONSULTANT FOR INTERPRETATION.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE (19MM) WAS EXPLANTED AFTER 0.70 MONTHS DUE TO AORTIC REGURGITATION. THE CUSTOMER REPORTED THAT A MAGNA 3000J19 WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) TO CORRECT AORTIC STENOSIS (AS) ON (B)(6) 2011. CORONARY AORTIC BYPASS GRAFT (CABG) WAS ALSO PERFORMED DURING THE OPERATION. AT IMPLANT, SEVERE CALCIFICATION WAS OBSERVED ON THE PATIENT'S AORTIC VALVE AND ANNULUS. A WEEK AFTER THE IMPLANT, PARAVALVULAR AND TRANSVALVULAR LEAKAGE WERE SUSPECTED ON THE ECHOCARDIOGRAPHY. THERE WERE NO HEALTH PROBLEMS DURING MONITORING PATIENT AFTER THE SURGERY; HOWEVER, THE CUSTOMER WAS CONSIDERING ABOUT THE LEAKAGE FOUND AGAIN ON THE ECHOCARDIOGRAPHY ON (B)(6) 2011 SO THAT CUSTOMER DECIDED TO PERFORM RE-AVR. MAGNA 3000J19 WAS EXPLANTED ON (B)(6) 2011 AND A 21MM VALVE WAS IMPLANTED AS A REPLACEMENT. AT EXPLANT, THE CUSTOMER SUSPECTED THE GAP BETWEEN THE LEAFLETS COULD BE THE CAUSE OF THE TRANSVALVULAR LEAKAGE. CUSTOMER ALSO COMMENTED THAT THIS PATIENT HAD SEVERE CALCIFICATION SO THAT STENT DISTORTION MIGHT HAVE OCCURRED DURING IMPLANT. CUSTOMER COMMENTED THAT THEY HELD THE LEAFLETS WITH TWEEZERS SO THAT THE LEAFLET WOULD PROBABLY HAVE A SERRATED MARK. THEY WERE UNABLE TO JUDGE WHETHER THIS EXPLANT WAS DEVICE RELATED BUT THAT THIS EXPLANT WAS NOT EXPECTED.

    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 10E111

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R