BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2160238 · Received July 13, 2011

    Report

    Report Number
    2015691-2011-15855
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PROLONGED OPERATION/BYPASS TIME. EVALUATION : DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE RECEIVED OPERATIVE REPORT INDICATES THAT THE SOURCE OF THE LEAK COULD NOT BE POSITIVELY IDENTIFIED. WITHOUT DEVICE RETURN AND EVALUATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE POSITIVELY IDENTIFIED BY EDWARDS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION OR QUALITY DEFICIENCY THAT MAY HAVE CAUSE OR CONTRIBUTED TO THIS EVENT.

    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 LEARNED THAT THE EDWARDS' AORTIC BIOPROSTHESIS WAS EXPLANTED AT IMPLANT DUE TO A PERIVALVULAR LEAK, AND REPLACED WITH SAME MODEL/SIZE EDWARDS VALVE WITH GOOD POSTOPERATIVE RESULTS. OPERATIVE REPORT INDICATES, "SEVENTEEN PLEDGETED NON-EVERTING SUTURES WERE PLACED AROUND THE ANNULUS AND THROUGH THE SEWING RING OF 23-MM MAGNA PERICARDIAL VALVE. IT WAS SEATED IN PLACE AND ALL SUTURES INDIVIDUALLY TIED. THE ANNULUS WAS INSPECTED AND THERE WAS NO CONCERN FOR ANY GAPS OR ANY POTENTIAL AREA OF LEAKS WITH A VALVE HOOK. AORTOTOMY WAS CLOSED IN THE USUAL FASHION, INNER LAYER HORIZONTAL MATTRESS, OUTER LAYER WHIPSTITCH WITH 4-0 PROLENE SUTURE. THE 2 VEIN GRAFTS WERE THEN ROUTED TO THE ASCENDING AORTA AND ANASTOMOSED END-TO-SIDE USING RUNNING 5-0 PROLENE SUTURE... AT THIS POINT, WHEN WE TRIED TO COME OFF AND NOTICED DARK BLOOD COMING FROM THE AREA OR THE CORONARY SINUS. THERE WAS A TEAR IN ITS PROXIMAL PORTION. IT WAS REPAIRED WITH PLEDGETED 4-0 PROLENE SUTURE. I NEEDED TO INTERMITTENTLY CLAMP THE ASCENDING AORTA IN ORDER TO DECOMPRESS THE HEART, BUT THE CORONARY SINUS WAS SUCCESSFULLY REPAIRED USING THIS TECHNIQUE...AS WERE COMING OFF CARDIOPULMONARY BYPASS, ROUTINE TEE EVALUATION SHOWED A PERIVALVULAR LEAK ALONG THE AREA OF THE RIGHT CORONARY ANNULUS. THE LEAK WAS SIGNIFICANT, WE WENT BACK ON FULL BYPASS AND RECLAMPED THE ASCENDING AORTA...THE AREA OF THE SUSPECTED LEAK WAS PROBED WITH A VALVE HOOK AND THOUGHT THAT WE SAW THE AREA OF THE LEAK AND SO, A 4-0 PROLENE SUTURES WAS PLACED THERE...AND AS WE CAME OFF CARDIOPULMONARY BYPASS, AGAIN THE LEAK WAS STILL THERE AND UNCHANGED. AT THIS TIME, THE LOCATION OF THE LEAK SEEMED TO BE DIFFERENT FROM WHERE WE FIRST THOUGHT IT WAS LOCATE. WE WENT BACK ON FULL BYPASS...NOT BEING SURE EXACTLY WHERE THE LEAK WAS, I DECIDED TO REMOVE THE VALVE AND PUT ANOTHER ONE IN...THE [SECOND VALVE] APPEARED TO SEAT WELL...HE WAS THEN WEANED OFF CARDIOPULMONARY BYPASS AND THIS TIME TEE EVALUATION SHOWED NO PERIVALVULAR LEAK". THERE HAS BEEN NO INFORMATION TO SUGGEST AN EDWARDS' DEVICE QUALITY DEFICIENCY.

    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-10L3267

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R