BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3160743 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20307
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY, REVIEWS AND CONCLUSIONS: THE EXPLANTED DEVICE WAS RETURNED AND EVALUATED; AS RECEIVED, ALL THREE LEAFLETS OF THE EXPLANT APPEAR TO BE HEAVILY MINERALIZED WITH LIMITED MOBILITY. THE TISSUE CALCIFICATION WAS CONFIRMED BY X-RAY IMAGING. THE CALCIFICATION APPEARS TO BE ¿EXTRINSIC¿ IN NATURE WHICH IS USUALLY SEEN IN THIS TYPE OF BIOPROSTHETIC VALVE ASSOCIATED WITH ENDOCARDITIS AND VEGETATION. TISSUE CALCIFICATION RELATED STRUCTURAL VALVULAR DETERIORATION IS THE MOST COMMON CHRONIC FAILURE MODE FOR BIOPROSTHETIC HEART VALVES. ALTHOUGH THE DETAIL UNDERLINE MECHANISM IS NOT FULLY UNDERSTOOD, THE BIOPROSTHETIC LEAFLET CALCIFICATION OBSERVED IN THIS PARTICULAR VALVE APPEARS TO BE ATTRIBUTABLE TO THE ENDOCARDITIS-MEDIATED VEGETATION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE EXPLANTED DEVICE HAS NOT YET BEEN RETURNED TO EDWARDS FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS BIOPROSTHETIC VALVE WAS EXPLANTED DUE TO ENDOCARDITIS APPROXIMATELY TWO YEARS AFTER IMPLANT. RECORDS INDICATE THE PATIENT'S PREOPERATIVE DIAGNOSIS AS UNSTABLE ANGINA, ACUTE CORONARY OCCLUSION WITH SEVERELY DETERIORATED BIOPROSTHETIC VALVE. OPERATIVE REPORT STATES, " (B)(6) FEMALE WHO UNDERWENT A MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT IN 2011 UTILIZING A #23 MM BIOPROSTHETIC VALVE. SHE APPEARED TO BE DOING QUITE WELL UNTIL THE ONSET OF ENDOCARDITIS IN 2012. THIS WAS BLOOD CULTURE POSITIVE AND EVIDENCE OF VEGETATION ON HER BIOPROSTHETIC VALVE. SHE WAS TREATED MEDICALLY AND APPEARED TO DO WELL. FOR THE RECENT 6 MONTHS, THERE HAS BEEN NOTED TO BE SOME DETERIORATION IN THE AORTIC VALVE FUNCTION; HOWEVER, IT HAD NOT REACHED SURGICAL SIGNIFICANCE. AT THIS POINT, SHE PRESENTED TO AN OUTSIDE INSTITUTION WITH UNSTABLE ANGINAL SYMPTOMS, WAS TRANSFERRED TO COOPER UNIVERSITY HOSPITAL FOR CARDIAC CATHETERIZATIONS. HER CARDIAC CATHETERIZATIONS REVEALED AN OSTIAL CIRCUMFLEX LESION WITH POOR FLOW TO THE OBTUSE MARGINAL CORONARY ARTERY. WITH SOME MINIMAL MANIPULATION OF THE CARDIAC CATH, THE PATIENT HAD VENTRICULAR FIBRILLATORY EPISODE REQUIRING DEFIBRILLATION. AN INTRAAORTIC BALLOON PUMP WAS PLACED AND SHE WAS REFERRED FOR EMERGENCY SURGERY TO REVASCULARIZE HER OBTUSE MARGINAL CORONARY ARTERY. IN ADDITION, IT WAS FELT THAT THE BEST THING TO DO WOULD BE TO REPLACE HER PRIOR DETERIORATING AORTIC VALVE AT THIS TIME. BECAUSE OF THE SECOND OPERATION IN A SHORT PERIOD OF TIME AND THE AGE OF (B)(6), A CHOICE OF MECHANICAL VALVE SEEMED TO BE APPROPRIATE." OPERATIVE FINDINGS INDICATE: "AT THE TIME OF SURGERY, TRANSESOPHAGEAL ECHOCARDIOGRAM DID CONFIRM A VERY POORLY FUNCTIONING AORTIC VALVE. UPON OPENING THE AORTA AND EXAMINING THE VALVE THIS APPEARED TO BE EXTREMELY CALCIFIC AND DESTROYED TRILEAFLET BIOPROSTHETIC VALVE, VERY FRIABLE, CALCIFIC MATERIAL ALONG THE ENTIRE LEAFLETS. VENTRICULAR FUNCTION WAS NONENAL BOTH PRE AND POST REVASCULARIZATION AND AORTIC VALVE REPLACEMENT. THE SAPHENOUS VEIN APPEARED TO BE GOOD FOR BYPASS GRAFTING AND THE CORONARY ARTERY APPEARED TO BE RELATIVELY NORMAL. UPON REMOVING THE BIOPROSTHETIC VALVE, THERE APPEARED TO BE SIGNIFICANT PANNUS INGROWTH. THIS WAS DEBRIDED AS MUCH AS POSSIBLE, BUT UNFORTUNATELY ONLY A 21 MM MECHANICAL VALVE COULD BE APPROPRIATELY SEATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260431 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX S-11B0637

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R