BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1739266 · Received June 25, 2010

    Report

    Report Number
    1820334-2010-00306
    Event Type
    Death
    Date Received
    June 25, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AND DEVICE CODES ARE LABELED IN THE IFU. EVENT EVAL: THE ZENITH DEVICE HAS COMPLETED REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE 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 EMPHASIZES THAT MORPHOLOGY SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF AN 18-22 FRENCH INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOGRAFT. ACCORDING TO TRAINING RECORDS, THE REPORTING PHYSICIAN COMPLETED CINC ZENITH AAA TRAINING ON 08/20/03. WITHOUT IMAGING AND PRE-IMPLANT DETERMINANTS WE ARE UNABLE TO COMMENT OF THE PATIENT'S SUITABILITY FOR EVAR. TORTUOSITY OF THE ILIAC ARTERIES WAS REPORTED. THE DEVICE WAS DEPLOYED OUT OF SEQUENCE PER THE IFU DUE TO DIFFICULTY IN CANNULATING THE CONTRALATERAL GATE. TORTUOSITY MAY HAVE CONTRIBUTED TO THE DIFFICULT CANNULATION. THE PHYSICIAN COMMENTED THAT THE SHEATH MAY HAVE RETRACTED DUE TO "SOME TORTUOSITY OF THE ILIAC ARTERY." THE PHYSICIAN FELT THAT THE COMPLAINT DEVICE WAS NOT AT FAULT FOR THE REPORTED DIFFICULTY. CINC CLINICAL EVAL CONCLUDED "LATROGENIC TEAR OF THE ILIAC ARTERY RESULTING IN HYPOTENSION AND DEATH." WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B) (6) FEMALE, PT, UNDERWENT AAA REPAIR ON (B) (6) 2010. THE PT HAD SOME TORTUOSITY OF THE ILIAC ARTERIES. CUT DOWNS WERE UNEVENTFUL. THE AREA REPRESENTATIVE OFFERED ENDOVASCULAR DILATORS AND THE PHYSICIAN DIDN'T FEEL THESE WERE NEEDED. THE MAIN BODY ADVANCED WITHOUT ANY RESISTANCE. THERE WERE PROBLEMS WITH CANNULATION AND DECIDED TO FINISH DEPLOYMENT OF IPSILATERAL SIDE, CAPTURE TOP CAP ETC. DURING THIS - THE MAIN BODY SHEATH DID PULL BACK A BIT. NO PROBLEMS WERE NOTED, BUT THE AREA REPRESENTATIVE DID MENTION TO THE SURGEON-THAT WE NEED TO WATCH IT IN CASE IT BACKED OUT OF THE ARTERY. THEY CONTINUED TO ATTEMPT CANNULATION FOR ABOUT 30MIN OR SO. ANESTHESIA BEGAN TO COMMENT ABOUT PRESSURE DROP. ABDOMEN WAS SOFT, SO PHYSICIAN DECIDED TO INJECT MAIN BODY SHEATH. CONTRAST INJECTION REVEALED A TEAR IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN DECIDED TO EXTEND THE GRAFT, WAS PREPPED ETC. WHEN READY TO ADVANCE GRAFT, PHYSICIAN DISCOVERED THAT GUIDEWIRE ACCESS WAS LOST. WHEN SURGEON ADVANCED WIRE IT APPEARED TO EXIT THE ARTERY THE RUPTURE SITE- THE PATH OF THE WIRE WAS NOWHERE NEAR THE MAIN BODY GRAFT ETC. THERE WAS NO WIRE ACCESS THROUGH THE GRAFT AT THIS TIME. PRESSURE CONTINUED TO DROP, BLOOD WAS ORDERED, FLUIDS HUNG AND CPR WAS BEGUN. SURGEON OPENED ABDOMEN AND WAS ABLE TO LIGATE THE RIGHT COMMON ILIAC ARTERY AS WELL AS RIGHT INTERNAL ILIAC ARTERY. BLEEDING WAS STOPPED. THE PT NEVER HAD A PULSE AFTER APPROXIMATELY 60MIN OF CPR ETC. SURGEON DECIDED TO END PROCEDURE. PHYSICIAN COMMENTED TO THE AREA REPRESENTATIVE THAT HE THOUGHT THAT THE MAIN BODY SHEATH HAD PERHAPS RETRACTED DISTAL TO SOME TORTUOSITY OF THE ILIAC ARTERY- AND AT SOME TIME IT WAS ACCIDENTALLY ADVANCED AND THIS CAUSED THE TEAR IN THE ARTERY. HE DID NOT BLAME THE GRAFT. HE ALSO SAID THAT DURING THE TIME OF EXTREMELY LOW BLOOD PRESSURE- THE PT COULD HAVE HAD A HEART ATTACK THAT COULD HAVE MADE RESUSCITATION IMPOSSIBLE.

    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 2497623

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death