BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3190339 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20424
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ADDITIONAL TESTING WAS CONDUCTED BY EDWARDS LIFESCIENCES RESEARCH AND DEVELOPMENT. R&D REPORT SUMMARY AND CONCLUSIONS ACCORDING TO THE OPERATIVE REPORT, THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO AORTIC REGURGITATION. IT WAS REPORTED THAT, ¿TOE REVEALED MODERATE AORTIC REGURGITATION WHICH APPEARED TO BE COMING FROM WITHIN THE SEWING RING AT THE COMMISSURE BETWEEN THE RIGHT AND NON-CORONARY CUSPS. LATER INSPECTION OF THE VALVE ON THE BACK TABLE DID REVEAL PROLAPSED OF ONE OF THE CUSPS.¿ NO ECHOCARDIOGRAPHY RECORDING WAS PROVIDED, THUS THE REPORTED AORTIC REGURGITATION AND THE BEHAVIOR OF THE VALVE IN VIVO CANNOT BE CONFIRMED. NON-CENTRAL LEAKAGE THROUGH THE SEWING RING AND STENT SUBASSEMBLY AREAS WERE DETECTED IN EDWARDS STANDARDIZED IN VITRO TESTING. THIS MAY CORRESPOND TO THE REPORTED REGURGITATION COMING FROM WITHIN THE SEWING RING AT THE COMMISSURE. NON-CENTRAL LEAKAGE THROUGH THE SEWING RING AND STENT SUBASSEMBLY AREAS IS TYPICAL FOR THIS TYPE OF BIOPROSTHESIS DURING THE INITIAL IMPLANT AND SHOULD BE EXPECTED TO REDUCE TO A NEGLIGIBLE LEVEL SHORTLY AFTER THE REVERSAL OF HEPARIN WITH PROTAMINE. ONE OF THE LEAFLETS (LEAFLET 1) IS SLIGHTLY LOWER AT THE CENTER OF COAPTATION UNDER PRESSURE WHICH APPEARS TO BE RELATED TO THE SMALL CENTRAL HOLE DURING THE PULSATILE TESTING. EDWARDS¿ STANDARDIZED IN VITRO TESTING DEMONSTRATES THAT THE IMMEDIATE FUNCTIONALITY OF THE VALVE IS ACCEPTABLE PER (B)(4):2005. THE UNSEALED, AS-RECEIVED VALVE SHOWED A 15.2 % REGURGITANT FRACTION, WHICH DECREASED TO 3.2 % AFTER SEALING. THIS SEALED TRF IS MORE THAN THREE TIMES LOWER THAN THE 10% ALLOWANCE PER (B)(4):2005 FOR THIS SIZE OF VALVE. THE SIGNIFICANT REDUCTION IN LEAKAGE AFTER SEALING DEMONSTRATED THAT THE MAJORITY OF THE REGURGITATION IS FROM NON-CENTRAL ORIGIN AS DESCRIBED ABOVE.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS NOT YET BEGUN. THE EVALUATION RESULTS WILL BE REPORTED IN A SUPPLEMENTAL MDR WHEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT OF PROLAPSED LEAFLET COULD NOT BE CONFIRMED BASED ON VISUAL OBSERVATION. AS RECEIVED, LEAFLET 1 APPEARED SLIGHTLY LOWER THAN LEAFLETS 2 AND 3 IN THE COAPTATION REGION. COMMISSURE 1 WIREFORM ALSO APPEARED SLIGHTLY BENT, AS EVIDENT IN THE X-RAY. NO VISIBLE INCONSISTENCIES OBSERVED ON REMAINING LEAFLETS. CUSTOMER PHOTOS WERE CONSISTENT WITH LAB FINDINGS. METHOD: X-RAY. DEVICE WAS RECEIVED AND DECONTAMINATION AT OUR (B)(4) FACILITY ON 14 JUNE 2013. DEVICE WAS THEN SHIPPED TO THE U.S. FOR PRODUCT EVALUATION WHICH WAS COMPLETED ON 12 JULY 2013. EVALUATION RESULTS ARE INCONCLUSIVE. THE VALVE WILL BE SENT TO RESEARCH AND DEVELOPMENT FOR FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SIZE 23 MM MAGNA EASE AORTIC VALVE IMPLANTED. THE PATIENT WAS TAKEN OFF BYPASS AND THE TOE SHOWED MODERATE REGURGITATION AROUND THE COMMISSURES. THE SURGEON PUT THE PATIENT BACK ON BYPASS TO INVESTIGATE. THE VALVE WAS REMOVED, AND ON REMOVAL IT WAS NOTICED ONE OF THE LEAFLETS HAD PROLAPSED. ANOTHER 23 MM WAS IMPLANTED. THE OPERATIVE REPORT WAS PROVIDED AND INCLUDES THE FOLLOWING STATEMENTS AFTER IMPLANT OF THE DEVICE: AT THIS TIME INSPECTION OF THE VALVE ON TOE REVEALED MODERATE AORTIC REGURGITATION WHICH APPEARED TO BE COMING FROM WITHIN THE SEWING RING AT THE COMMISSURE BETWEEN THE RIGHT AND NON-CORONARY CUSPS. IT WAS FELT THAT THIS WAS TOO SIGNIFICANT TO LEAVE AND CARDIOPULMONARY BYPASS WAS THEREFORE RE-INSTITUTED. THE AORTIC CROSS CLAMP WAS APPLIED AND ANTEGRADE FOLLOWED BY RETROGRADE CARDIOPLEGIA ADMINISTERED. THE AORTOTOMY WAS RE-OPENED AND THE PATCH REMOVED. THE AORTIC VALVE WAS INSPECTED AND APPEARED TO BE COMPLETELY NORMAL. THERE DID NOT APPEAR TO BE ANY TECHNICAL ERRORS WITH IMPLANTING THE VALVE. HOWEVER, GIVEN THE REGURGITATION ON TOE, I DID NOT FEEL COMFORTABLE LEAVING THE VALVE THE IN-SITU AND THEREFORE I EXPLANTED IT. LATER INSPECTION OF THE VALVE ON THE BACK TABLE DID REVEAL PROLAPSE OF ONE OF THE CUSPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290818 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 13B027

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R