BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 4128855 · Received September 15, 2014

    Report

    Report Number
    1820334-2014-00429
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN (B)(6) MALE PT WHO PREVIOUSLY HAD AAA REPLACEMENT WITH A Y-GRAFT (MANUFACTURER UNK) IN 2011 UNDERWENT RUPTURED AAA REPAIR URGENTLY. L1 WAS 40MM AND THE ACCESS VESSEL, THE LEFT FEMORAL WAS 9MM OF THE ARTIFICIAL VESSEL. AT 15:00, THE PHYSICIAN PLACED THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER AT THE SUSPECTED, RUPTURED SITE, THE ANASTOMOTIC PART OF THE Y-GRAFT IN THE PROXIMAL SIDE. AT 15:30, THE PT'S BLOOD PRESSURE DECREASED TO UNDER 40 AND HIS CONDITION WORSENED SUDDENLY. AT 15:45, THE PHYSICIAN CONFIRMED THAT THERE WAS BLEEDING BY DSA, BUT COULD NOT LOCATE THE EXACT BLEEDING SITE. IMMEDIATELY THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY. AROUND 17:00, EXACT BLEEDING SITE STILL COULD NOT BE CONFIRMED BY LAPAROTOMY. AROUND 17:30, THE Y-GRAFT AND THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER WERE REPLACED WITH A NEW ONE ARTIFICIAL VESSEL. AROUND 20:00, THE PT TAKEN TO THE ICU AFTER SURGERY. THE PT IS OUT OF CRITICAL CONDITION, BUT STILL IN UNPREDICTABLE CONDITION. ADD'L INFO ABOUT THE DEATH PROVIDED ON 09/02/2014. THE DATE OF DEATH IS CORRECTED TO (B)(6) 2014. ON (B)(6) 2014, THE PHYSICIAN DETERMINED THE BLEEDING FROM THE AORTA HAD NOT STOPPED, SO ANOTHER OPEN SURGERY WAS PERFORMED. HE TREATED THE ANASTOMOTIC PART. HE ALSO CONFIRMED THE ISCHEMIA OF THE COLON, BUT COULD NOT REMOVE ANY NECROTIC PART. ON (B)(6) 2014, THE PT HAD DIC FROM MASSIVE HEMORRHAGE DUE TO AORTA RUPTURE. THEN HE DECEASED DUE TO SEPTICEMIA FROM BOWEL ISCHEMIA (NECROSIS) DUE TO PROLONGED INTERRUPTION OF BLOOD FLOW OF THE AORTA. THE AUTOPSY FOUND NECROSIS OF THE DESCENDING COLON. THE PHYSICIAN COMMENTED AS BELOW: I CAN'T SAY THERE WAS NO RELATION BETWEEN THIS EVENT AND THE CONVERTER GRAFT BECAUSE THE BLEEDING STARTED AGAIN AFTER INSERTION OF THE DEVICE. HOWEVER, AFTER CONSIDERING PT'S CONDITION (AORTA RUPTURE), AND DEVICE WHICH COULD BE USED AT THAT POINT, IT COULDN'T BE HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569375 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH COOK, INC. NA 4080887

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R