BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD WOVEN DOUBLE VELOUR PLATINUM GRAFT

    MDR report key: 2051287 · Received April 6, 2011

    Report

    Report Number
    2242352-2011-00238
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WILL NOT BE AVAILABLE FOR EVALUATION. WITHOUT THE RETURNED DEVICE A TECHNICAL EVALUATION CAN NOT BE PERFORMED. METHOD: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. RESULTS: THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THERE ARE NO SIMILAR OR OTHER COMPLAINTS AGAINST THE BATCH. A MEDICAL OPINION CONFIRMED THAT IT IS NOT UNUSUAL TO HAVE A CERTAIN AMOUNT OF OOZING SINCE THE PERFUSION BRANCH IS SUBJECTED TO AN AVERAGE OF 5 1/MIN FLOW AND THE SHEAR STRESS IS VERY HIGH AS A CONSEQUENCE. PROTAMINE IS NORMALLY ADMINISTERED AT THE END OF THE PROCEDURE REGARDLESS OF ANY BLEEDING. IT IS USED TO 'REVERSE" THE HEPARIN GIVEN BEFORE THE PROCEDURE AND SHOULDN'T BE SEEN AS A THERAPEUTIC INTERVENTION DUE TO THE BLEEDING OBSERVED. THE FACT THAT THE OOZING STOPPED AND THE SURGEON DECIDED TO LEAVE THE GRAFT IN PLACE ARE INDICATIONS THAT THE PATIENT WASN'T AT RISK OF ANY POSSIBLE COMPLICATION DUE TO THE OBSERVED CONDITION. THERE IS NO INDICATION IN THE COMPLAINT IF A TRANSFUSION WAS REQUIRED. ALSO NO SPECIMEN WAS SENT FOR FURTHER INVESTIGATION. THE PATIENT RECOVERED FROM THE SURGERY AS EXPECTED AND WAS DISCHARGED FROM THE HOSPITAL. FOLLOWING OUR INVESTIGATION, BASED UPON THE ABOVE, OUR CONCLUSION TO THE MOST PROBABLE ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AORTIC VALVE REPLACEMENT AND ASCENDING AORTA REPLACEMENT WERE PERFORMED. BLOOD LEAKED FROM THE BRANCH JUST AFTER BLOOD WAS SENT TO THE BRANCH. BLOOD LEAKAGE CONTINUED DURING OPERATION. THE AMOUNT OF BLOOD LEAKAGE WAS ABOUT 1 L. AFTER OPERATION WAS FINISHED, PROTAMINE WAS ADMINISTERED AND PROCEDURE WAS COMPLETED. THE PRODUCT WAS NOT RETRIEVED FROM THE HOSPITAL. INVESTIGATION IS REQUIRED. THE DOCTOR SAID HE WOULD NOT USE HEMASHIELD UNLESS CAUSE FOR BLOOD LEAKAGE IS SOLVED AND PRODUCT IS IMPROVED. WE RECEIVED THE ADDITIONAL INFORMATION ON (B)(6) 2011, AND (B)(6) 2011: ((B)(6)). THE LEAKING OCCURRED FROM HOLE WALL OF THE BRANCH. SLIGHT OOZING WAS OBSERVED IN THE TRUNK. THERE WAS NOT A SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE BLEEDING. PROVIDED BY THE SALES REP ON (B)(6) 2011. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE REMAINS IMPLANTED. NO PORTION OF THE DEVICE IS AVAILABLE. PICTURES AND VIDEO ARE ALSO NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD WOVEN DOUBLE VELOUR PLATINUM GRAFT VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 175826P 12843622

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other