BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8 MM

    MDR report key: 4172435 · Received October 10, 2014

    Report

    Report Number
    2242352-2014-01088
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL COMPLAINT NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR AND RECEIVED BOTH CORONARY BYPASS AND AORTIC VALVE REPLACEMENT FOR STENOSIS. AFTER COMPLETING VALVE REPLACEMENT, DISTAL CORONARY ANASTOMOSIS AND CLOSURE OF THE AORTA, THE CROSS CLAMP WAS REMOVED AND PROXIMAL CORONARY ANASTOMOSIS WAS ATTEMPTED WITH HS III PROXIMAL SEAL SYSTEM 3.8 MM. THE AORTA MEASURED 28 MM AND RECEIVED A 25 MM REPLACEMENT VALVE. THE CONDITION OF THE AORTA SHOWED SOME SOFT ATHEROMA WITHOUT CALCIFICATIONS. THREE SUCCESSIVE HS III PROXIMAL SEAL SYSTEM 3.8 MM WERE ATTEMPTED, WITH SUBSEQUENT TEARS OF THE AORTIC PUNCH SITE DUE TO THE HEARTSTRING TENSION SPRING FAILING TO EXTRACT FROM THE DELIVERY DEVICE. AORTIC MEAN PRESSURES THROUGHOUT THE PROCESS RANGED FROM 55-94 MMHG UNTIL A CROSS CLAMP WAS REAPPLIED TO COMPLETE THE REPAIR OF THE AORTA AND ANASTOMOSIS OF THE PROXIMAL CORONARY GRAFTS. THE TORN PORTION OF THE AORTA WAS REPAIRED WITH A COMBINATION OF PLEGETED 3-0 AND 5-0 PROLENE SUTURES. THE PT HAD NO NEUROLOGICAL DEFICIT WITH NO PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642950 HS III PROXIMAL SEAL SYSTEM 3.8 MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25094775

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other