BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1822022 · Received September 1, 2010

    Report

    Report Number
    2015691-2010-13976
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO INCONSISTENCIES DETECTED, THE VALVE WILL BE SENT TO RESEARCH AND DEVELOPMENT FOR FUNCTIONAL TESTING. OCT 5,2010 - RESEARCH AND DEVELOPMENT COMPLETED THE FUNCTIONAL REPORT AND CONCLUDED WITH THE FOLLOWING: IT WAS INITIALLY REPORTED THAT, "THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO "SEVERE MITRAL REGURGITATION". A SMALL AMOUNT OF REGURGITATION WAS DETECTED BY EDWARDS USING STANDARDIZED IN VITRO TESTS. SOME PORTION OF THE SMALL TOTAL REGURGITATION DID OCCUR THROUGH THE CENTER OF THE VALVE. HOWEVER, THE TOTAL REGURGITANT FRACTION MEASURED IS MORE THAN 4 TIMES LESS THAN THE 20% MAXIMUM ALLOWED FOR THIS SIZE VALVE PER (B)(4) AND WOULD NOT GENERALLY BE CONSIDERED "SEVERE" MITRAL REGURGITATION. THE TEE REVIEW CONDUCTED BY A THIRD PARTY CONCLUDED: THE MITRAL BIOPROSTHESIS IS NORMAL IN APPEARANCE AND APPEARS NORMAL IN FUNCTION. THERE IS A SMALL CENTRAL MITRAL REGURGITATION JET THAT IS ENTIRELY NORMAL FOR THIS PERICARDIAL BIOPROSTHESIS THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.REQUESTS WERE MADE FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATIOIN IS ONGOING. THE DEVICE WAS RETURNED FOR EVALUATION, ANALYSIS IS PENDING.THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER (B)(4) SALES REPRESENTATIVE THAT A BENT SPIKE WAS FOUND WHEN THE PATIENT CHANGED THE FACTORY TIP PROTECTOR TO THE DISCONNECT CAP BY CLEAN FLASH. THE CUSTOMER REPORTED THIS OCCURRED AFTER THE TRANSFER SET WAS CHANGED TO THE NEW ONE. THE TRANSFER SET HAD BEEN IN USE FOR ONE DAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO SEVERE MITRAL REGURGITATION. A COMPETITOR'S VALVE WAS IMPLANTED AS A REPLACEMENT. PLEASE SEND RETURN KIT. THE SALES REPRESENTATIVE IS TO FOLLOW UP WITH ADDITIONAL INFORMATION AT A LATER TIME. ON 08/20/10 TELEPHONE REQUEST FOR PATIENT INFO. AND ECHO CD. PATIENT INFORMATION IS TO BE EMAILED OR MAILED AND ECHO TO MAILED TO ME EARLY NEXT WEEK

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS. THE PHYSICIAN WENT IN TO EXPLANT THE LEAD AND IT WAS FOUND TO BE FRACTURED. THE PATIENT DID SUFFER A PREVIOUS NON DEVICE RELATED FALL, AND THAT WAS THOUGHT TO HAVE CONTRIBUTED TO THE FRACTURE. THERE WERE SEVERAL INAPPROPRIATE MODE SWITCHES FOUND IN THE ARRHYTHMIA LOGBOOK AS WELL. THE DEVICE WAS EXPLANTED AT THE SAME TIME TO AVOID ANY FUTURE ADDITIONAL SURGERIES FOR THIS PATIENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX R-10F1540

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention