BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2531726 · Received April 12, 2012

    Report

    Report Number
    2015691-2012-17262
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED BY EDWARDS LABORATORY, THEN FORWARDED FOR FUNCTIONAL PERFORMANCE TESTING. RESULTS AS FOLLOWS: AS RECEIVED, LEAFLET 2 COAPTS BELOW THE OTHER TWO LEAFLETS AS THE UN-PRESSURIZED VALVE SITS IN AIR. THE SEWING RING CLOTH IS MOSTLY INTACT WITH A FEW DISRUPTIONS NOTED ON THE INFLOW SIDE AS WELL AS REMNANT SUTURES, MOST LIKELY FROM THE IMPLANT/EXPLANT PROCEDURE. THE FREE MARGIN OF LEAFLET 1 IS CUT NEAR THE CENTER OF THE VALVE IMPRESSIONS ARE PRESENT ON THE OUTFLOW SURFACE OF ALL LEAFLETS, CONSISTENT WITH FORCEPS MARKS, MOST LIKELY OCCURRING DURING EXPLANT. THESE ABNORMALITIES IN THE AS-RECEIVED VALVE WOULD NOT PASS THE QUALITY INSPECTION DURING MANUFACTURING AT EDWARDS. X-RAY IMAGING REVEALS THE WIREFORM AND STIFFENER BAND ARE INTACT. THEN, FUNCTIONAL TESTING WAS PERFORMED IN A PULSE DUPLICATOR UNDER NORMAL PHYSIOLOGICAL CONDITIONS. LEAFLET APPEARANCE AT OPENING AND CLOSING APPEARS NORMAL, WITH LEAFLETS 2 AND 3 COAPTING BELOW LEAFLET 1. NO CENTRAL HOLE IS APPARENT WHEN THE VALVE IS CLOSED. THE TOTAL REGURGITANT FRACTION (TRF) FROM THE PULSATILE TEST IS 1.6%. THIS TRF LEVEL IS MORE THAN SIX TIMES LESS THAN THE 10% MAXIMUM ALLOWED FOR THIS SIZE VALVE PER ESTABLISHED STANDARDS AND REGULATIONS. CONCLUSIONS: AS THE INTRAOPERATIVE ECHOCARDIOGRAPHY HAS NOT BEEN PROVIDED, THE BEHAVIOR OF THE VALVE AND REPORTED PARAVALVULAR LEAKAGE OBSERVED IN VIVO COULD NOT BE CONFIRMED OR EVALUATED. UPON REVIEW OF PROVIDED INFORMATION, RECORDS, AND TESTING, THE ROOT CAUSE OF THIS EXPLANT CANNOT BE DETERMINED. THE AVAILABLE INFORMATION AND EDWARDS INVESTIGATION INDICATES NOTHING TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION NOT YET COMPLETED. THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEGUN. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE EVALUATION RESULTS AND CONCLUSIONS WILL BE REPORTED ONCE COMPLETED.

    Description of Event or Problem · 1

    OPERATIVE REPORT INDICATES, " THE SIZERS WERE USED, 23 [MM] WAS PICKED. AFTER PLACING 3 SUTURES, ONE ON EACH COMMISSURE, THE ANNULUS WAS BROUGHT TO THE SURGICAL FIELD. THE PATIENT HAD A VERY FLOPPY ANNULUS....THE VALVE WAS SEATED ON THE ANNULUS...WE SLOWLY WEANED THE PATIENT OFF THE CARDIOPULMONARY BYPASS. THIS WAS DONE WITHOUT ANY DIFFICULTIES...AT THIS POINT, TRANSESOPHAGEAL ECHOCARDIOGRAM INTRAOPERATIVELY SHOWED SEVERE AI. AT THE END OF PROTAMINE, THERE WAS NO CHANGE IN THE SEVERITY OF THE AI.... PER TEE, WE BELIEVE THAT THERE WAS PERIVALVULAR LEAK BETWEEN THE NON AND RIGHT CORONARY CUSPS...UNDER METICULOUS INSPECTION, THERE WAS NO PERIVALVULAR SPACE ON CIRCUMFERENTIAL CAREFUL INSPECTION...[VALVE WAS REMOVED, AND REPLACED WITH ANOTHER SAME MODEL/SIZE VALVE]... WE USED PLEDGETED SUTURES CIRCUMFERENTIALLY AROUND THE ANNULUS. THE ANNULUS AGAIN WAS EXTREMELY FLOPPY. THE VALVE WAS NICELY SEATED[WITH NO FURTHER COMPLICATIONS] THE PATIENT TOLERATED THE PROCEDURE AND IN STABLE CONDITION WITH GOOD HEMODYNAMICS."

    Description of Event or Problem · 1

    IT WAS REPORTED AN AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT DUE TO INTRAOPERATIVE FINDING OF PERIVALVULAR LEAK. THE VALVE WAS REPLACED WITH SAME MODEL, LARGER SIZE 25MM VALVE. IT WAS REPORTED THAT THE PV LEAK WAS NOTICED AFTER GOING OFF PUMP. THE SURGEON REPORTED HE BELIEVED THERE WAS PERIVALVULAR LEAK BETWEEN THE NON AND RIGHT CORONARY CUSPS. ALSO REPORTED, TWO ATTEMPTS WERE MADE TO EVALUATE AND MITIGATE THE PERIVALVULAR LEAK PRIOR TO EXPLANT AND REPLACEMENT WITH THE LARGER VALVE. TOTAL PUMP TIME WAS 5 HOURS, 48 MINUTES. NO ALLEGATION OF VALVE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-11H2783

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R