BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    MDR report key: 2890566 · Received December 20, 2012

    Report

    Report Number
    9680654-2012-00002
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    WILLIAM A. COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE GRAFT HAD NOT MOVED AND A SCALLOP PRESENT IN THE GRAFT AT THE LEVEL OF THE SMA PREVENTED THE GRAFT WAS OBSTRUCTING THE SMA. OTHER PATIENT FACTORS ARE LIKELY TO BE THE MAIN CONTRIBUTORS OF THIS EVENT (SUCH AS DEHYDRATION SECONDARY TO THE RUPTURED PANCREATIC ARTERY PSEUDOANEURYSM). COOK WILL ENDEAVOR TO OBTAIN MORE INFORMATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER A FULL EVALUATION HAS BEEN CONDUCTED BY THE MANUFACTURER. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED ON (B)(6) 2012 AND ON (B)(6) 2012 PATIENT PRESENTED TO EMERGENCY ROOM WITH SEVERE DIARRHEA DUE TO POSSIBLE SEVERE IBD FLARE UP, SHE HAD ALSO BEEN TO THE DENTIST WHERE SHE TOOK ANTIBIOTICS AND FELT FINE PRIOR. SHE WAS EVALUATED WITH A NON-CONTRAST CT SCAN DUE TO ELEVATED CREATININE WHICH WAS INCONCLUSIVE. A CONTRAST CTA WAS DONE THE NEXT DAY SHOWING BOTH KIDNEYS ALMOST COMPLETELY INFARCTED AND THE RUPTURED PANCREATIC ARTERY PSEUDOANEURYSM. THE INTERVENTIONAL RADIOLOGIST COILED THE PANCREATIC ARTERY ANEURYSM EMERGENTLY. THE VASCULAR SURGEON THEN INTERVENED THE SMA AND PLACED A STENT. HE DID NOT TRY TO INTERVENE THE RENAL ARTERIES DUE TO AMOUNT OF INFARCTION OF KIDNEYS. THE SURGEON COULD NOT FIND ANY MOVEMENT OF PROXIMAL ZENITH FENESTRATED DEVICE ON CT. THE SMA WAS ACCOMMODATED WITH A SCALLOP SO NOTHING SHOULD HAVE BEEN CROSSING IT. AS OF (B)(6) 2012 THE PATIENT IS ALIVE AND IN ICU. SHE IS APPARENTLY DOING MUCH BETTER, BUT WILL BE RESTRICTED TO PERMANENT DIALYSIS DUE TO UN-REPAIRABLE DAMAGE TO THE KIDNEYS. IT WAS REPORTED THAT THE PATIENT BECAME VERY DEHYDRATED IN THE PROCESS OF RUPTURING THE PANCREATIC ARTERY AS WELL AS HER EXTREME DIARRHEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY NONE MIH WILLIAM A. COOK AUSTRALIA NA AC907382

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| O ATRIUM STENTS