BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2161715 · Received July 8, 2011

    Report

    Report Number
    1820334-2011-00362
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY WAS REPORTED. TOP CAP DIFFICULTY IN REMOVING IS ADDRESSED IN THE PHYSICIANS REFERENCE MANUAL. DEVICE SUBASSEMBLY WAS RETURNED TO ASSIST WITH 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 END USER. EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE INSTRUCTIONS FOR USE FOR THE MAIN BODY GRAFT STATES: "READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS AND PRECAUTIONS MAY LEAD TO SERIOUS CONSEQUENCES OR INJURY TO THE PATIENT." SPECIFICALLY, THE IFU LISTS KEY ANATOMIC CRITERIA THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING. THE RENU IFU ALSO STATES: "THE ZENITH RENU AAA ANCILLARY GRAFT IS AVAILABLE AS EITHER A STRAIGHT COMPONENT (ZENITH RENU AAA MAIN BODY EXTENSION) SYSTEM OR A LONGER TAPERED COMPONENT (ZENITH RENU AAA CONVERTER) SYSTEM FOR SECONDARY ENDOVASCULAR INTERVENTION IN PATIENTS HAVING RECEIVED PRIOR ENDOVASCULAR REPAIR OF INFRARENAL ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS IN WHICH THERE IS INADEQUATE PROXIMAL FIXATION OR SEAL." ALL TRAINED PHYSICIANS HAVE ACCESS TO A PHYSICIANS REFERENCE MANUAL THAT LISTS TROUBLESHOOTING TECHNIQUES IF THIS FAILURE MODE IS TO OCCUR. (B)(4). THE RETURNED DEVICE WAS EXAMINED BY INTERNAL PERSONNEL. THE FOLLOWING FINDINGS WERE OBSERVED DURING THE COURSE OF THE INVESTIGATION: THE EXTERIOR SIDEPORT OF THE TOP CAP APPEARED TYPICAL AFTER USE. THERE EXISTED A SLIGHT BEND IN THE CANNULA JUST DISTAL TO THE PIN VISE. THERE EXISTED A SLIGHT BEND IN THE CANNULA JUST DISTAL TO THE TOP CAP. THE TOP CAP WAS DISSECTED LENGTH WISE, AND CIRCUMFERENTIAL SCRATCHES WERE NOTED, INDICATING THE DEVICE WAS TWISTED AT SOME POINT DURING THE PROCEDURE. IT WAS CONCLUDED THAT THE FAILURE MODE IN THIS CASE WAS DIFFICULT TO RELEASE, AS A RESULT OF A DIFFICULT TO REMOVE TOP CAP DURING THE PROCEDURE. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION IN THIS CASE, AND SIMILARITIES WITH OTHER EVENT DESCRIPTIONS WITH THIS FAILURE MODE. THIS FAILURE MODE IS INCLUDED IN THE SCOPE OF CAPA. (B)(4). WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2011. THE PATIENT HAD A STRAIGHT FORWARD ANATOMY, NO TORTUOSITY OR ANGULATION IN NECK. THE DEVICE WAS TRACKED STRAIGHT UP; THERE WAS NO TWISTING OF THE DEVICE, PHYSICIAN PULLED THE PROXIMAL TRIGGER WIRE TO RELEASE THE TOP CAP AND TRIED TO ADVANCE THE INNER CANNULA; HOWEVER, THE TOP CAP DID NOT MOVE UP. THE PHYSICIAN PUSHED HARD AND STILL NO MOVEMENT OF THE TOP CAP. EVENTUALLY HE WAS ABLE TO PUSH TOP CAP OFF; HOWEVER, THE DEVICE LANDED MUCH LOWER THAN ORIGINALLY PLACED. THERE WAS NO TYPE I PROXIMAL LEAK PRESENT ON THE FINAL ANGIOGRAM. ADDITIONAL FINAL ANGIOGRAMS WERE RAN TO ENSURE THE DIFFICULTY DID NOT CONTRIBUTE TO AN ENDOLEAK AS WELL AS VERIFY THE DEVICE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2432546

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR