BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 2926243 · Received January 16, 2013

    Report

    Report Number
    1820334-2013-00036
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    COOK IN
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PT UNDERWENT AAA REPAIR ON (B)(6) 2012. ONCE THE GREY POSITIONER WAS REMOVED THROUGH THE MAIN BODY EXTENSION DELIVERY SHEATH, THERE WAS A SIGNIFICANT LOSS OF BLOOD AS IT SQUIRTED THROUGH THE VALVE. THE CODA BALLOON WAS THEN PUT THROUGH THE SHEATH VALVE AS QUICKLY AS POSSIBLE WHICH SLOWED THE FLOW OF BLOOD FORM THE VALVE. HOWEVER, WHEN THE BALLOON NEEDED TO BE REMOVED TO CLOSE THE ACCESS INCISIONS, THERE WAS ANOTHER SIGNIFICANT FLOW OF BLOOD FROM THE VALVE. THE PT WAS ESTIMATED TO HAVE LOST 500ML OF BLOOD DURING THESE TWO SHORT TIME PERIODS THAT ONLY THE WIRE WAS THROUGH THE VALVE, WHICH WERE UNAVOIDABLE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. APART FORM MORE THAN USUAL BLOOD LOSS DURING THE PROCEDURE, NO ADVERSE EFFECTS TO THE PT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24742 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK IN NA 2836366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other