BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1511523 · Received October 20, 2009

    Report

    Report Number
    2015691-2009-11877
    Event Type
    Injury
    Date Received
    October 20, 2009
    Date of Event
    August 18, 2009
    Report Date
    September 23, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INCONSISTENCIES DETECTED, THE VALVE SENT FOR FUNCTIONAL TESTING. 11/19/09 RESEARCH AND DEVELOPMENT CONCLUDED WITH THE FOLLOWING: "THIS VALVE WAS REPORTEDLY EXPLANTED AT IMPLANT DUE TO ¿AN ECCENTRIC JET¿. THE ECHO RECORDING WAS NOT PROVIDED; THEREFORE IT WAS NOT POSSIBLE TO VERIFY THE NATURE AND EXTENT OF THE AORTIC REGURGITATION EXPERIENCED IN VIVO. A SMALL TO MODERATE AMOUNT OF NON-CENTRAL LEAKAGE WAS OBSERVED IN THE EDWARDS STANDARDIZED FUNCTIONAL TESTS, WHICH APPEARS TO BE THROUGH THE STENT/BAND ASSEMBLY AND MAY BE THE LEAKAGE OBSERVED IN VIVO. HOWEVER, THE TOTAL REGURGITANT FRACTION (TRF) IS MORE THAN TWO TIMES LESS THAN THE MAXIMAL ALLOWANCE FOR THIS SIZE VALVE. INITIAL STENT LEAKAGE IS TYPICAL FOR THIS TYPE OF BIOPROSTHETIC VALVE AND SHOULD BE REDUCED TO A NEGLIGIBLE LEVEL SHORTLY AFTER THE ADMINISTRATION OF PROTAMINE TO REVERSE THE EFFECTS OF HEPARIN DURING THE INITIAL OPERATION. NEVERTHELESS, GIVEN THE BLOOD EXPOSURE AND FORMALIN STORAGE HOWEVER, IT IS POSSIBLE THAT THE VALVE BEHAVIOR OBSERVED IN THE EDWARDS LABORATORY IS DIFFERENT FROM THE BEHAVIOR EXPERIENCED IN THE CLINIC. " NO INCONSISTENCIES DETECTED.THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ECHOCARDIOGRAPHY RESULTS: THE AORTIC BIOPROSTHESIS APPEARS WELL SEATED, AND INITIALLY IS ASSOCIATED WITH MILD REGURGITATION IN THREE SMALL JETS. THE TWO SMALL JETS THAT APPEAR TO ORIGINATE AT THE POSTERIOR COMMISSURAL POSTS LIKELY ARE VALVULAR IN ORIGIN, BUT APPEAR LESS PROMINENT WITH LATER IMAGING, SUGGESTING POSSIBLE RESOLUTION. THE LARGER ANTERIOR JET (ORIGINATING NEAR THE INTERVENTRICULAR SEPTUM) LIKELY IS PARAVALVULAR IN ORIGIN.ON 1/11/2010- RD REVIEWED REPORT SUMMARY: "THIS VALVE WAS.¿ REPORTEDLY EXPLANTED AT IMPLANT DUE TO ¿AN ECCENTRIC JET¿. A SMALL TO MODERATE AMOUNT OF NON-CENTRAL LEAKAGE WAS OBSERVED IN THE EDWARDS STANDARDIZED FUNCTIONAL TESTS, WHICH APPEARS TO BE THROUGH THE STENT/BAND ASSEMBLY. THESE FINDINGS ARE CONSISTENT WITH THE RESULTS FROM ECHOCARDIOGRAPHY. ¿THE TWO SMALL JETS THAT APPEAR TO ORIGINATE AT THE POSTERIOR COMMISSURAL POSTS LIKELY ARE VALVULAR IN ORIGIN, BUT APPEAR LESS PROMINENT WITH LATER IMAGING, SUGGESTING POSSIBLE RESOLUTION. THE IN VIVO ECHO IMAGES INDICATE THAT THESE TWO JETS ARE LIKELY THROUGH THE STENT ASSEMBLY AREAS (WHICH WERE REDUCED IN LATER IMAGING) AS OBSERVED IN THE IN VITRO FUNCTIONAL TESTS, WHILE THE ¿THE LARGER ANTERIOR JET (ORIGINATING NEAR INTERVENTRICULAR SEPTUM) LIKELY IS PARAVALVULAR IN ORIGIN.¿ THE TOTAL REGURGITANT FRACTION (TRF) IS MORE THAN TWO TIMES LESS THAN THE ISO (B) (4) MAXIMAL ALLOWANCE FOR THIS SIZE VALVE. INITIAL STENT LEAKAGE IS TYPICAL FOR THIS TYPE OF BIOPROSTHETIC VALVE AND SHOULD BE REDUCED TO A NEGLIGIBLE LEVEL SHORTLY AFTER THE ADMINISTRATION OF PROTAMINE TO REVERSE THE EFFECTS OF HEPARIN DURING THE INITIAL OPERATION. THE OBSERVATIONS OF THE ECHOCARDIOGRAPHY ARE CONSISTENT WITH THE EDWARDS LABORATORY RESULTS. "

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS. REQUESTS WERE MADE VIA E-MAIL FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, DEVICE WAS RETURNED FOR EVALUATION, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    A FALSE NEGATIVE HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A SONOGRAM PERFORMED A WEEK LATER INDICATED THAT THE PATIENT WAS PREGNANT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED HCG RESULT.

    Description of Event or Problem · 1

    REPORTEDLY A 3000, 25MM VALVE WAS EXPLANTED AT IMPLANT. THE EVENT WAS DESCRIBED AS, ¿AN ECCENTRIC JET WAS VISIBLE BY ANESTHESIA COMING OFF PUMP. IT DID NOT DISSIPATE AFTER ADMINISTERING PROTAMINE.¿ THE VALVE WAS REPLACED WITH ANOTHER 3000 25MM ¿ 2007167, NO ISSUES WITH THE SECOND VALVE. OPERATIVE REPORT AND INTER. OP. ECHO. WAS REQUESTED FROM SALES REP. SALES REPRESENTATIVE INDICATED TO CONTACT THE SURGEON¿S OFFICE FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER MEDWATCH REPORTS THAT THE SURGEON WAS USING A LAPAROSCOPIC NEEDLE ASPIRATOR TO PUNCTURE THE GALLBLADDER AND A SHARP POINT BROKE OFF THE INSTRUMENT. THE RISK MGR REPORTS VIA TELEPHONE THAT THE PIECE WAS RETRIEVED WITHOUT INCIDENT OR DELAY IN THE PROCEDURE AND THE SURGEON DID NOT FEEL IT WAS NECESSARY TO X-RAY SINCE THE PIECES MATCHED. A CHOLECYSTECTOMY WAS BEING PERFORMED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000 R-08J1899

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention