BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT CONVERTER

    MDR report key: 2033070 · Received March 18, 2011

    Report

    Report Number
    1820334-2011-00150
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEATH IS ADDRESSED IN THE IFU. DIFFICULT DEPLOYMENT IS NOT SPECIFICALLY LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE 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 INSTRUCTIONS FOR USE (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 PT." 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 PTS 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. CONTROLS ARE IN PLACE FOR THE SOLDERING PROCESS ENSURING THE BARBS, ON THE SUPRARENAL STENT, HAVE THE CORRECT AMOUNT OF SOLDER AND CORRECT AMOUNT OF SPACING BETWEEN THE STENT STRUTS AND BARB WIRE. 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. ADDITIONAL REQUESTS FOR IMAGING HAVE BEEN MADE. COMMUNICATION WITH THE COOK INCORPORATED SALES REP CONFIRMED THAT THE COOK AX1 RENU DEVICE WAS USED OFF LABEL AND THAT IT WAS USED AS PRIMARY TREATMENT OF THE PT. RENU DEVICES ARE ONLY APPROVED AS SECONDARY INTERVENTION DEVICES, NOT FOR PRIMARY TREATMENT. A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED OR REPORTED AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE IN THE FUTURE, THIS REPORT WILL BE AMENDED AT THE APPROPRIATE TIME. CORRECTIVE ACTION WAS ISSUED TO ENGINEERING ON (B)(6) 2009. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) OLD FEMALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2011. THE RIGHT RENAL ARTERY AND SUPERIOR MESENTERIC ARTERY, WHICH WERE AT THE SAME LEVEL, WERE COVERED BY THE FABRIC OF THE GRAFT; HOWEVER LEFT REMAINED OPEN. DURING DEPLOYMENT OF THE ZENITH GRAFTS, THE ZENITH RENU AAA ANCILLARY GRAFT CONVERTER HAD DIFFICULTY CONCERNING THE TOP CAP. THE TOP CAP WAS MOVED UPWARD TO LIBERATE BARE STENT, AS MORE FORCE WAS APPLIED TO MOVE THE TOP CAP UPWARD, THE CAP SUDDENLY MOVED UP WITH THE GRAFT. THE PHYSICIAN IMMEDIATELY MADE NOTICE AFTER ANGIO WAS RAN AND DECIDED TO STENT THE SUPERIOR MESENTERIC ARTERY, WHICH WAS SUCCESSFUL. THE RIGHT RENAL COULD NOT BE STENTED. AFTER THE PROCEDURE, THE PT WAS DOING WELL WITH GOOD PERFUSION. PT WAS DOING FINE UNTIL (B)(6) 2011. THE PT WAS STILL ADMITTED AND HER HEALTH BEGAN TO DETERIORATE. THE PT'S SUPERIOR MESENTERIC ARTERY STENT OCCLUDED AND THE PT DIED ON (B)(6) 2011 OF ISCHEMIA TO MAJOR ORGANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2400616

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death