BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 1893490 · Received November 8, 2010

    Report

    Report Number
    2015691-2010-14333
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. ACCORDING TO THE OP REPORT, THE PATIENT WAS RECOMMENDED FOR MVR TO CORRECT MITRAL REGURGITATION. THE VALVE WAS IMPLANTED AND TAKEN OFF CBP WHEN THE PATIENT DEVELOPED A PERIVALVULAR LEAK AT THE MEDIAL COMMISSURE WHERE THE PATIENT WAS FOUND TO HAVE SIGNIFICANT CALCIFICATION WHICH HAD REQUIRED DECALCIFICATION OF THE ANNULUS PRIOR TO SUTURE PLACEMENT. THE PATIENT WAS PLACED BACK ON CBP AND 4-0 PROLENE PLEDGETED STITCHES WERE PLACED AT THE LEAK AREA. THE PATIENT WAS SEPARATED FROM CBP ONCE AGAIN WITHOUT ANY DIFFICULTY. AS THEY WERE READY TO CLOSE THE PATIENT CONTINUED TO HAVE SOME SIGNIFICANT BRIGHT RED BLEEDING FROM THE BEHIND THE HEART. EVERY ATTEMPT WAS MADE TO EVALUATE AND REPAIR AS THE BLEEDING WAS NOTICED AT THE POSTERIOR ASPECT OF THE ATRIUM R AV GROOVE. SUTURE STITCHES WERE APPLIED AND ALSO BIOGLUE WAS APPLIED. THE PATIENT CONTINUED TO HAVE SIGNIFICANT BLEEDING AND THE DECISION WAS MADE TO GO BACK ON PUMP. NOW THE DECISION WAS MADE TO POSSIBLY TAKE THE VALVE TO EVALUATE FOR ATRIAL DISSOCIATION BECAUSE IT WAS A PULSATILE FLOW AT THE AV GROOVE. THE VALVE WAS EXPLANTED AND THE ATRIUM AND VENTRICLE WERE EVALUATED WITH NO SIGNIFICANT LESIONS THAT CAUSE THE BLEEDING WERE FOUND. A PATCH WAS APPLIED TO CONTROL THE BLEEDING. AS THE PATIENT HAD BEEN ON PUMP FOR QUITE AWHILE, AN INTRAAORTIC BALLOON PUMP WAS PLACED, AND THE PATIENT WAS RETURNED TO THE ICU IN CRITICAL CONDITION. ATRIAL DISSOCIATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 10/19/2010 AND 10/26/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    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-10A0101

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention