BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3180775 · Received June 20, 2013

    Report

    Report Number
    2015691-2013-20389
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED, MECHANICAL DAMAGE WAS EVIDENT NEAR THE FREE MARGIN OF LEAFLET 1 AT COMMISSURE 2, DAMAGE DID NOT PENETRATE LEAFLET AND APPEARED TO BE CAUSED BY BLUNT TOOL, LENGTH OF DAMAGE WAS APPROX 6 MM. LEAFLET 2 ALSO HAD A CUT FROM THE FREE MARGIN EXTENDING NEAR THE STENT, CUT WAS APPROX 11 MM IN LENGTH. COMMISSURE 2 WIREFORM WAS EXPOSED ON THE OUTFLOW, WIREFORM BETWEEN COMMISSURE 1 AND 2 WAS ALSO EXPOSED ON THE INFLOW ASPECT. SEWING RING WAS RECEIVED CUT BETWEEN COMMISSURE 1 AND 2. NO VISIBLE CALCIFICATION WAS OBSERVED ON THE LEAFLETS. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES, ALSO KNOWN AS AORTIC INSUFFICIENCY, OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. TRIVIAL/TRACE TO MILD AMOUNTS OF AR ARE NOT UNUSUAL POST OPERATIVELY IN BIOPROSTHETIC VALVES. THIS IS USUALLY TOLERATED BY THE PATIENTS. IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. TYPICALLY, MILD REGURGITATION IS NOT UNUSUAL AFTER INITIAL VALVE REPLACEMENT, AND IS USUALLY TOLERATED BY PATIENTS. OFTEN MODERATE TO HIGH REGURGITATION REQUIRING RE-OPERATION IN THE IMMEDIATE POST-OPERATIVE PERIOD IS DUE TO PROCEDURAL RELATED ISSUES AND IS UNRELATED TO THE DEVICE. THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. UNFORTUNATELY, THE REPORT OF INSUFFICIENCY COULD NOT BE CONFIRMED BASED ON VISUAL OBSERVATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 MONTHS DUE TO AORTIC INSUFFICIENCY (AI). PER THE OP REPORT, THE PATIENT EXPERIENCE EPISODES OF CONGESTIVE HEART FAILURE. CARDIAC ECHOCARDIOGRAM REVEALED SEVERE AI WITHOUT ANY OBVIOUS VEGETATIONS. DURING EXPLANTATION OF THE OLD PROSTHETIC VALVE, THERE WAS NO EVIDENCE OF INFECTION. THERE WERE NO HOLES IN THE LEAFLETS AD WELL. OVERALL, THE VALVE WAS STIFF BUT THE SURGEON WAS UNABLE TO LOCATE AN OBVIOUS CAUSE FOR THE AI. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. POST BYPASS TEE SHOWED THE AORTIC VALVE LEAFLETS OPENING WELL WITHOUT PERIVALVULAR LEAK. NO OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280075 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R