BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2001543 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14909
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    October 9, 2010
    Report Date
    January 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - STITCH AT THE COMMISSURES BETWEEN THE RIGHT CORONARY CUSP AND THE NON-CORONARY CUSP HAD A TEAR WHERE THE SUTURE ON THE AORTIC WALL. 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. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. ACCORDING TO THE OPERATIVE REPORT: "NEXT, WE MOVED OUR ATTENTION TO THE AORTIC VALVE. WE MADE A TRANSVERSE AORTOTOMY INCISION NEAR THE AORTIC ROOT. THE AORTIC VALVE WAS EXPOSED. THERE WAS NO CALCIFICATION NOTED BUT THE LEAFLET APPEARED TO BE QUITE THICK SUGGESTIVE OF CONTRACTURE OF THE LEAFLET. WE THEN EXCISED ALL THREE LEAFLETS OF THE AORTIC VALVE...WE THEN SIZED THE AORTIC ROOT AND IT WAS NOT VERY BIG AND THE AORTIC ANNULUS COULD ONLY ACCOMMODATE SIZE #19 PERICARDIAL VALVE. AFTER THE 21 STITCHES WERE APPLIED AROUND THE MITRAL ANNULUS AND THEN APPLIED TO THE RING OF THE AORTIC VALVE WAS SEEDED IN THE SUPRA-ANNULAR POSITION AND ALL STITCHES WERE TIED...THE PATIENT WAS THEN SLOWLY REWARMED...THE AORTIC CROSS-CLAMP WAS THEN REMOVED WHILE THE ASCENDING AORTA WAS IN THE LOW PRESSURE SUCTION. THE PATIENT WAS CONTINUED TO BE REWARMED; HOWEVER, WE NOTICED THAT THERE WAS BLEEDING FROM THE AORTIC ROOT JUST BETWEEN THE AORTIC ROOT AND THE RIGHT ATRIAL JUNCTION. WE ATTEMPTED TO APPLY TWO HORIZONTAL MATTRESS SUTURES WITH THE PLEDGETS BUT IT APPEARED TO CONTINUE TO BLEED. SO WE DECIDED TO GO BACK ON THE CARDIOPULMONARY PUMP AND MORE CARDIOPLEGIC SOLUTION WAS GIVEN UNTIL THE HEART BECAME ASYSTOLE. NEXT, WE THEN REMOVED THE AORTOTOMY INCISION SUTURES. THE AORTIC VALVE WAS REENTERED. INSPECTION OF THE AORTIC VALVE SHOWED NO DESTRUCTION OF THE LEAFLETS BUT INSTEAD BUT WE NOTICED THE STITCH RIGHT UNDERNEATH THE COMMISSURE BETWEEN THE RIGHT CORONARY CUSP AND NON-CORONARY CUSP. SO WE DECIDED THAT THIS SUTURE WAS ON THE AORTIC WELL AND STARTED TO BLEED OUTSIDE OF THE AORTA AND DISSECTED BETWEEN THE AORTIC ROOT AND THE BASE OF THE RIGHT ATRIUM. SO WE DECIDED TO PUT THE PATIENT BACK ON CARDIOPULMONARY PUMP, AND THE AORTA WAS CROSS-CLAMPED AGAIN AND MORE CARDIOPLEGIC SOLUTION WAS GIVEN TO THE AORTIC ROOT...ON INSPECTION OF THE AORTIC VALVE, WE NOTICED THAT THE STITCH AT THE COMMISSURES BETWEEN THE RIGHT CORONARY CUSP AND THE NON-CORONARY CUSP HAD A TEAR WHERE THE SUTURE ON THE AORTIC WALL, AND THIS EXPLAINED THE BLEEDING OUTSIDE OF THE AORTA, AND THEN DISSECTION BETWEEN THE AORTIC ROOT AND THE VASE OF THE LEFT ATRIUM, SO WE DECIDED TO REDO THE AORTIC VALVE REPLACEMENT."

    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-09L2721

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention