BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2021078 · Received March 16, 2011

    Report

    Report Number
    2015691-2011-15035
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 13, 2010
    Report Date
    February 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: PER THE DISCHARGE SUMMARY, IT WAS LEARNED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2010. TWO ADDITIONAL DEVICES REMAIN IMPLANTED. ALTHOUGH NO CAUSE OF DEATH WAS PROVIDED BY THE HEALTH CARE PROVIDER, THE DISCHARGE SUMMARY PROVIDED THE FOLLOWING NARRATIVE: ON (B)(6) 2010, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT. THE PATIENT DID NOT DO WELL AFTER THE SURGERY. SHE DEVELOPED A SIGNIFICANT BLEEDING. SHE ALSO REQUIRED SIGNIFICANT INOTROPIC SUPPORT. UPON ARRIVAL TO THE ICU, THE PATIENT WAS RESUSCITATED AND CONTINUED WITH CRITICAL CARE. THE FAMILY HAD ALREADY BEEN NOTIFIED OF HER POOR CONDITION AND THEY GRANTED HER DNR. HER CONDITION CONTINUED TO DETERIORATE. SHE BECAME SEVERE METABOLIC ACIDOSIS AND HER INOTROPIC SUPPORT HAD BEEN INCREASED SIGNIFICANTLY. THE FAMILY WANTED TO WITHDRAW THE SUPPORT. THE PATIENT EXPIRED. THE SURGEON'S RESPONSE DOES NOT INDICATE THAT THE DEVICE IS AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    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

    THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO ATRIOVENTRICULAR SEPARATION. THE SURGEON DID NOT INDICATE IN HIS RESPONSE THAT THE EXPLANT OF THIS DEVICE WAS DUE TO A DEVICE MALFUNCTION. PER THE (B)(6) 2011 OPERATIVE REPORT: THE MITRAL VALVE WAS INSPECTED. THE ANNULUS WAS SEVERELY CALCIFIED. THE LEAFLETS WERE RESECTED. THE ANNULUS WAS SIZED. CALCIFICATIONS MADE IT SO TIGHT THAT THEY COULD ONLY ACCEPT A #21 VALVE. IT IS TOO SMALL; THEREFORE, WE DECIDED TO DO SOME DECALCIFICATION. MOST OF THE CALCIUMS WERE IN THE POSTERIOR LEAFLET "DECALCIFICATION WAS PERFORMED" ANNULUS WAS ENLARGED TO ACCEPT A #29 VALVE, SUTURES WERE PASSED THROUGH THE SEWING RING OF THE VALVE, THE VALVE WAS SEATED AND THE SUTURES WERE TIED. THERE WAS GOOD APPOSITION BETWEEN THE ANNULUS AND THE SEWING RING. THE 3 LEAFLETS WERE MOVING EASILY WITHOUT ANY OBSTRUCTION. A LEFT VENTRICULAR VENT WAS THEN PLACED VIA A STAB WOUND ON THE PULMONARY VEIN. THE LEFT ATRIUM WAS THEN CLOSED USING PROLENE SUTURES. THE PATIENT WAS REWARMED.. CROSSCLAMP REMOVED. HEART WAS REPERFUSED.. SINUS RHYTHM RE-ESTABLISHED. THE PATIENT WAS IN SINUS TACHYCARDIA; THEREFORE, SHE WAS PLACED AT THE RATE OF 80. LUNGS WERE VENTILATED. DE-AIRING PERFORMED VIA THE LEFT VENTRICULAR VENT AND VIA THE ASCENDING AORTA NEEDLE. AT THAT TIME, WE NOTICED THAT THERE WAS A LOT OF BLEEDING COMING OUT FROM THE BACK OF THE HEART. CAREFUL INSPECTION WITH SLIGHT ELEVATION OF THE HEART SHOWED A HEMATOMA AND BLEEDING FROM THE AV GROOVE POSTERIORLY. THIS IS VERY SUGGESTIVE OF ATRIOVENTRICULAR SEPARATION AT THE MITRAL VALVE ANNULUS. WE THOUGHT THE BEST WAY TO REPAIR THIS IS TO GOING BACK ON PUMP AND TAKE DOWN THE MITRAL VALVE, REPAIR THE AV SEPARATION, AND REDO THE MITRAL VALVE. THE PATIENT WAS THEN PLACED BACK ON PUMP. SHE HAS NOT BEEN REVERSE OF HEPARIN. ALL THE CANNULAS WERE STILL IN PLACE. THE CROSS-CLAMP WAS THEN RE-APPLIED AND CARDIOPLEGIA WAS AGAIN GIVEN TO ARREST THE HEART. THE LEFT ATRIUM WAS THEN AGAIN RE-ENTERED. THE MITRAL VALVE WAS THEN TAKEN DOWN. THERE WAS A SEPARATION OF THE VENTRICLE FROM THE ATRIUM FOR A DISTANCE OF ABOUT 2 CM POSTERIORLY. THIS SEPARATION OCCURRED AT THE AREA WHERE THE CALCIFICATION WAS DEBRIDED. WE PLACED SEVERAL PROLENE SUTURES WITH LARGE FELT PLEDGET FROM THE VENTRICLE TOWARD THE ATRIUM TO CLOSE THE SEPARATION. WE THEN PATCHED THAT AREA WITH PERICARDIUM USING 3-0 PROLENE. THE VALVE SUTURES THEN AGAIN APPLIED FROM THE VENTRICLE TOWARD THE ATRIUM. THIS TIME, THE ANNULUS CAN ONLY ACCEPT A #25 VALVE. A #25 BOVINE PERICARDIAL EDWARDS MAGNA VALVE WAS CHOSEN. THE VALVE WAS THEN SEATED AND THE SUTURES WERE TIED. THERE WAS GOOD APPOSITION BETWEEN THE ANNULUS AND THE SEWING RING. THE 3 LEAFLETS WERE MOVING EASILY WITHOUT OBSTRUCTION.

    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 AT THE TIME OF IMPLANT. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-09H1772

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R