BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW AORTIC PERICARDIAL HEART VALVE

    MDR report key: 2687150 · Received August 3, 2012

    Report

    Report Number
    3004478276-2012-00007
    Event Type
    Death
    Date Received
    August 3, 2012
    Date of Event
    July 15, 2012
    Report Date
    August 3, 2012
    Manufacturer
    SORIN GROUP CANADA INC., MITROFLOW DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN THE PROCESS OF BEING RETURNED TO THE COMPANY FOR EVALUATION AND WILL UNDERGO GROSS-EXAMINATION AND MORPHO-HISTOLOGICAL ANALYSIS AT A REFERENCE LABORATORY UPON RECEIPT. METHOD: THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE SUBJECT VALVE WERE PULLED AND REVIEWED BY QUALITY CONTROL AT SORIN GROUP (B)(4) INC., MITROFLOW DIVISION. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A 12A23 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. RESULTS: NO DEFINITIVE RESULTS AT THIS TIME. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME AS THE DEVICE HAS NOT BEEN EVALUATED.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2012, THAT A MITROFLOW VALVE (12A23 S/N: (B)(4)) HAD BEEN EXPLANTED ON (B)(6) 2012, AFTER APPROX 7.3 YEARS DUE TO REPORTED AORTIC STENO-INSUFFICIENCY RESULTING FROM STRUCTURAL VALVE DETERIORATION. THE DEVICE WAS REPLACED WITH A ST. JUDE MEDICAL TRIFECTA BIOPROTHESIS - SIZE 23 MM. AS REPORTED, THE PT DIED (B)(6) DAYS AFTER THE INTERVENTION DUE TO SEPTIC SHOCK. THE IMPLANT REPORT FROM 2005, PROVIDED BY THE HOSPITAL, INDICATES THAT AT THE TIME THIS MITROFLOW VALVE WAS IMPLANTED, THE PT'S AORTIC VALVE AND AORTIC ANNULUS WERE CALCIFIED. IN ADDITION TO RECEIVING THE MITROFLOW VALVE IN 2005, A CORONARY BY-PASS WAS PERFORMED DURING THE PROCEDURE. ACCORDING TO THE EXPLANT REPORT, IN ADDITION TO THE REPLACEMENT OF THE MITROFLOW VALVE, THE ASCENDING AORTA WAS REPORTED TO BE FRAGILE AND WAS REPLACED ABOVE THE CORONARY ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITROFLOW AORTIC PERICARDIAL HEART VALVE TISSUE, HEART VALVE LWR SORIN GROUP CANADA INC., MITROFLOW DIVISION 12A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R