BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1882554 · Received October 22, 2010

    Report

    Report Number
    1820334-2010-00544
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 2010
    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). PERFORATION IS LABELED IN THE IFU. NO PRODUCT WAS RECEIVED TO ASSIST IN THIS INVESTIGATION. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SENT WITH INSTRUCTIONS FOR USE (IFU), WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE IFU STATES: "AFTER ENDOVASCULAR GRAFT PLACEMENT PTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT..." THE FAILURE MODE ASSIGNED TO THIS CASE IS, "PERFORATION." THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION IN THE EVENT EVAL FORM SUPPLIED, AS WELL AS THE PHYSICIAN'S COMMENTS "I SUSPECT THAT PERFORATION OF THE AORTA BY SUPRARENAL STENT ITSELF CAUSED THE FORMATION OF NEW ANEURYSM. THE AORTA COULD BE INFECTED BY THE INTERFERENCE OF THE SMALL INTESTINE DUE TO THE PERFORATION." A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED OR REPORTED AT THIS TIME, AS VERY LITTLE INFO WAS RECEIVED FOR THIS CASE. ADDITIONALLY, IMAGING WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. DISCUSSIONS WITH INTERNAL CLINICAL PERSONNEL THEORIZED THAT THE PT MAY HAVE SUFFERED A PSEUDO ANEURYSM OR EVEN PROGRESSION OF DISEASE THAT LED TO THE PERFORATION OF THE VESSEL, HOWEVER, IT IS UNCLEAR AT THIS TIME, THE TRUE ROOT CAUSE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. THE RISK IS CONSIDERED ACCEPTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2008, AN (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. NO NOTABLE EVENTS WERE OBSERVED. AT A FOLLOW-UP (DATE UNK), NEW ANEURYSM FORMATION NEAR THE RENAL ARTERY WAS FOUND. ON (B)(6) 2010, THE PHYSICIAN CUT THE SUPRARENAL STENT AND CLIPPED THE AORTA, THEN CUT AND REMOVED THE AORTA AREA. THEN HE REPLACED AN ARTIFICIAL VESSEL, AND THEN PERFORMED THE BYPASS OPERATION FOR THE RENAL ARTERY. THE PT'S CONDITION AFTER THE PROCEDURE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA F2167431

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention