BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2073423 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15391
    Event Type
    Death
    Date Received
    May 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE OPERATIVE REPORT STATES: "THE OPERATION WAS COMPLICATED AND HE NEEDED A FURTHER MITRAL VALVE REPLACEMENT AND A FURTHER AORTIC VALVE REPLACEMENT DUE TO THE POOR VIEW WITH THE AORTIC PROSTHESIS IN PLACE." SEE REPORT FOR SERIAL NUMBER (B)(4). OPERATIVE REPORT CONCLUDED WITH THE STATEMENT "I WOULD GIVE THE CAUSE OF DEATH AS BIVENTRICULAR FAILURE, PROSTHETIC VALVE ENDOCARDITIS (MITRAL), AORTIC AND MITRAL VALVE DISEASE (OPERATED). THE OPERATIVE REPORT INDICATES THAT THERE WAS EVIDENCE OF ENDOCARDITIS. HOWEVER, NO INFORMATION HAS BEEN MADE AVAILABLE WHICH IDENTIFIES THE SOURCE AND TYPE OF INFECTION. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: THERE ARE MANY FACTORS THAT COULD RESULT IN THE NEED TO EXPLANT AND REPLACE A VALVE, THE MOST COMMON OF WHICH IS REGURGITATION. THESE COMPLICATIONS CAN HAVE MANY ROOT CAUSES, INCLUDING BUT NOT LIMITED TO PATIENT FACTORS, (AGE, DISEASE STATES, COMORBIDITIES), PHARMACOLOGICAL FACTORS, OR PROCEDURE FACTORS. IT IS TYPICALLY NOT RELATED TO PRODUCT MALFUNCTION. ALTHOUGH THERE ARE MULTIPLE ROOT CAUSES, VALVES ARE TYPICALLY EXPLANTED BECAUSE THEY ARE NOT FUNCTIONING OPTIMALLY. IN THIS CASE, THE SURGEON INDICATED THAT THERE WAS EVIDENCE OF ENDOCARDITIS (OF THE MITRAL VALVE) AND POOR TISSUE QUALITY AT START OF IMPLANT. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. UNFORTUNATELY, THE SURGEON DID NOT PROVIDE THE SOURCE OR TYPE OF INFECTION AND THERE WAS NO RECORD OF A PATHOLOGY REPORT OR AUTOPSY.

    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, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 3 MONTHS 7 DAYS (3.23 MONTHS). PER THE OPERATIVE REPORT, THE PATIENT UNDERWENT AORTIC AND MITRAL VALVE REPLACEMENT ON (B)(6) 2011. THE OPERATION WAS COMPLICATED. HE REMAINED BREATHLESS AFTER THAT AND HAD A TTE ON THE (B)(6) 2010, WHICH WAS SAID TO SHOW JETS OF REGURGITATION - ONE OF WHICH SEEMED TO BE PARAVALVULAR. HE CONTINUED TO DECLINE THROUGHOUT (B)(6) AND WAS ADMITTED AS AN EMERGENCY ON (B)(6) 2011 IN EXTREMIS. HE PERKED UP A LITTLE OVERNIGHT AND WAS CPAP OXYGENATING BETTER, BUT THROUGH THE EARLY HOURS OF (B)(6), HE DETERIORATED REQUIRING INTUBATION AND SWH. PRE-OPERATIVE TOE'S DONE ON THE 7TH AND 8TH SHOWED SEVERE MITRAL REGURGITATION WITH DEHISCENCE OF MOST OF THE VALVE RING BETWEEN ABOUT 1 O'CLOCK AND 5 O'CLOCK AS THE SURGEON LOOKED AT THE VALVE. "I HAD A DISCUSSION WITH COLLEAGUES ABOUT THE MERITS AND DE-MERITS OF OPERATING ON THIS MAN. MY VIEW WAS THAT HE WOULD DIE WHATEVER HAPPENED. THEIR VIEW WAS THAT (B)(6) MERITED AN ATTEMPT AT SALVAGE." OPERATIVE FINDINGS: THERE WAS A REPAIR STITCH IN THE LEFT SIDE OF THE AORTA IN THE AORTOPULMONARY GROOVE. THE PERIMOUNT VALVE HAD DEHISCED THROUGH ALMOST THREE QUARTERS OF ITS CIRCUMFERENCE. WHEN TUGGED ON IT LIFTED OUT BRINGING WITH IT MOST OF THE PLEDGETS. ONE OR TWO OF THE SUTURES HAD BROKEN. THE VALVE WAS COVERED IN EITHER CLOT OR VEGETATIONS. THE ENDOCARDIUM OF THE ATRIUM AND THE VALVE LEAFLETS HAD DEHISCED THROUGH 330 DEGREE OF THE ANNULUS. THE VALVE SEEMED TO HAVE REMAINED IN POSITION BY SITTING IN THIS GROOVE. AT 9 O'CLOCK, THERE WAS AN AREA OF LEFT ATRIAL AND MITRAL VALVE LEAFLET THAT BORE NO MARKS OF SUTURE OR IMPRESSION OF PLEDGET. THE ENTIRE NATIVE MITRAL VALVE WAS STILL INSITU. THE LEFT VENTRICLE WAS BIG AND FUNCTIONED POORLY. THE RIGHT VENTRICLE AT THE BEGINNING OF THE PROCEDURE WAS FUNCTIONING MODERATELY POORLY. THE RIGHT ATRIUM WAS SMALL. THERE WERE VEGETATIONS ON THE PACING LEAD. I REMOVED THE MITRAL VALVE AND REPLACED IT WITH A 31-MM PERIMOUNT USING INTERRUPTED BUTTRESSED ETHIBOND SUTURES. THE VALVE SEATED DOWN NICELY. A FEW OF THE SUTURES CUT THROUGH AND HAD TO BE REPLACED (POOR TISSUE QUALITY). THE ATRIUM WAS CLOSED WITH TWO LAYERS OF PROLENE AND DE-AIRED. THE FCC WAS REPAIRED AND THE AORTA WAS CLOSED WITH TWO LAYERS OF PROLENE. THE HEART WAS DE-AIRED AND BYPASS WAS RE-STARTED. AT NORMOTHERMIA WE RE-STARTED THE BALLOON PUMP. I PUT HIM ON BIG DOSES OF ADRENALINE, NORADRENALIN, MILRINONE AND VASOPRESSIN AND ATTEMPTED TO WEAN FROM BYPASS. BOTH VENTRICLES VERY QUICKLY FAILED. THE PROCEDURE WAS TERMINATED AND DEATH DECLARED AT THAT POINT. THE CAUSE OF DEATH AS BIVENTRICULAR FAILURE, PROSTHETIC VALVE ENDOCARDITIS (MITRAL), AORTIC AND MITRAL VALVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 10H180

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| R