BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1940015 · Received December 28, 2010

    Report

    Report Number
    2015691-2010-14596
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. A COPY OF THE PRE-OPERATIVE ECHO CD HAS BEEN REQUESTED BUT NOT YET RECEIVED. BOTH THE IMPLANT AND EXPLANT OPERATIVE REPORTS WERE REQUESTED AND RECEIVED. THE EXPLANT OPERATIVE REPORT PROVIDED THE FOLLOWING INFORMATION: "[THE PATIENT] WAS DOING WELL AND WAS DISCHARGED FROM THE HOSPITAL, DOING WELL. ALL OF A SUDDEN LAST MONDAY HE DEVELOPED SHORTNESS OF BREATH AND LOWER EXTREMITY EDEMA. H WAS ADMITTED... 10 DAYS AFTER THE SURGERY. SINCE THEN, AN ECHO WAS DONE WHICH SHOWED THE PATIENT HAS SEVERE AI AND CONGESTIVE HEART FAILURE. A TEE SHOWED THAT THE PATIENT HAD A LARGE PERIVALVULAR LEAK." INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, SUTURE THREADS ARE NOTED IN THE SEWING RING. THE LEAFLETS ARE INTACT AND THE X-RAY DEMONSTRATES AN INTACT WIREFORM. EDWARDS STANDARDIZED IN VITRO TESTING OF THE AS-RECEIVED VALVE SHOWED A 9.3% TOTAL REGURGITANT FRACTION. THIS AMOUNT OF REGURGITATION IS APPRECIABLE; ALTHOUGH IT IS LESS THAN THE 15% MAXIMUM ALLOWED PER ISO5840:2005 FOR THIS SIZE VALVE. SUBSEQUENT RE-TESTING OF THE VALVE WITH THE SEWING RING SEALED REDUCED THE LEAKAGE BY A FACTOR OF 4, DEMONSTRATING THAT THE LEAKAGE WAS PARAVALVULAR IN NATURE. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE EXTENT TO WHICH THE DISRUPTIONS IN THE SEWING RING COULD HAVE CONTRIBUTED TO THE REGURGITATION SEEN IN VIVO IS UNKNOWN. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS RELATED TO THIS DEVICE WAS COMPLETED AND THE RESULTS DEMONSTRATE THAT THE DEVICE MET ALL SPECIFICATIONS. A DISRUPTION IN THE SEWING RING OF THE SIZE AND EXTENT PRESENT ON THE AS-RECEIVED VALVE WOULD NOT PASS VISUAL INSPECTION AT EDWARDS.

    Description of Event or Problem · 1

    THE SURGEON TOLD THE SALES REP THAT THERE WAS A HOLE IN THE VALVE AND THE DEVICE WAS SENT TO HOSPITAL PATHOLOGY FOR CULTURE (TO RULE OUT ENDOCARDITIS). THE PATIENT IS FINE AND WAS IMPLANTED WITH ANOTHER MAGNA EASE VALVE. BOTH IMPLANT AND EXPLANT OPERATIVE REPORTS WERE PROVIDED BY THE SURGEON. THE IMPLANT WAS UNREMARKABLE WITH THE FOLLOWING NOTATIONS "THE AORTA WAS SEVERELY CALCIFIED AND ACTUALLY WAS NOT MOVING AT ALL SO I HAD TO PRY THIS OPEN AND REMOVE THE AORTIC VALVE LEAFLET USING PICKUP AND SCISSORS COMPLETELY... THERE WAS A LOT OF CALCIUM IN THE ANNULUS." PER THE EXPLANT OPERATIVE REPORT, THE DEVICE WAS EXPLANTED 15 DAYS POST-IMPLANT, DUE TO SEVERE AORTIC INSUFFICIENCY AND PERIVALVULAR LEAK DETECTED ON ECHO. THE REPORT STATES "RIGHT AT THE LEFT CORONARY CUSP, THERE WAS AN AREA THAT HAS DEHISCED WHICH WAS CAUSING THE SEVERE PERIVALVULAR LEAK... THERE WAS SOME CALCIUM STILL LEFT IN THE ANNULUS. THIS WAS ALL REMOVED. " TOTAL IMPLANT DURATION WAS 15 DAYS (0.50 MONTHS).

    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-10H2263

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R