BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 4201142 · Received October 27, 2014

    Report

    Report Number
    2953200-2014-02188
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, CONCLUSION: 24 OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (AORTIC NECK DIAMETER <(><<)>19MM.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS MODERATE AORTIC NECK ANGULATION, MODERATE CALCIFICATION, AND THE DIAMETER OF THE AORTIC NECK BELOW THE RENAL ARTERIES WAS 18 MM. THE STENT GRAFTS WERE IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN MODELLED THE STENT GRAFT WITH A RELIANT BALLOON. THERE WAS A SMALL BULGING OF THE RELIANT BALLOON ON THE LEFT SIDE OF THE PATIENT¿S AO AORTIC NECK. THE BALLOON WAS INSIDE OF THE DEPLOYED BIFURCATED GRAFT. DURING THE MODELLING OF THE STENT GRAFT THE ABDOMINAL AORTA NECK WAS RUPTURED/PERFORATED. THE RELIANT BALLOON ACHIEVED HEMOSTASIS, AND THEN IMPLANTED AN ENDURANT AORTIC CUFF 25X25X49 WITHIN THE 25 MM BIFURCATED STENT GRAFT. THE AORTIC CUFF SUCCESSFULLY TREATED THE RUPTURED/PERFORATED AORTIC NECK. THE AORTIC LIMBS HAD THROMBUS IN THEM AND PHYSICIAN USED BALLOONS AND ANGIOJET SYSTEMS TO REMOVE THROMBUS FROM LIMBS. PATIENT WAS STABLE WITH HEMOSTASIS. THE PATIENT WAS SENT TO RECOVERY, PATIENT HAD HEART ATTACK AND EXPIRED. FILMS WERE REVIEWED; REVIEW OF RETURNED PRE-IMPLANT CTA¿S REVEALED THAT THE PROXIMAL NECK WAS 18MM IN DIAMETER, 3CM IN LENGTH, AND SEVERELY CALCIFIED. THE NECK WAS ANGULATED 55DEG (P-A). THE MAX DIAMETER AAA MEASURED 5CM AND CONTAINED THROMBUS. THE DISTAL AORTA WAS SMALL (13MM DIAMETER) AND SEVERELY CALCIFIED, AND BOTH ILIACS WERE 9-10MM IN DIAMETER, NON-TORTUOUS, AND MODERATELY CALCIFIED. REVIEW OF ANGIOGRAM IMAGES AT IMPLANT REVEALED THAT THE PROXIMAL NECK FLOW LUMEN DIAMETER (L-R) WAS APPROXIMATELY 18MM JUST BELOW THE RENALS, AND 3.5 CM BELOW THE RENALS AT THE START OF THE ANEURYSM MEASURED 16MM. THE MAX DIAMETER AAA WAS 5 CM AND CONTAINED THROMBUS (3CM MAX FLOW LUMEN). THE DISTAL AORTA WAS SMALL (13MM) AND BOTH ILIACS APPEARED ESSENTIALLY STRAIGHT. BOTH ILIACS WERE BALLOONED. FROM THE RIGHT SIDE, THE BIFURCATE WAS IMPLANTED JUST BELOW THE RENALS, AND THE IPSI LIMB WAS IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY. THE CONTRA LIMB CROSSED OVER THE IPSI LIMB AND WAS THEN IMPLANTED INTO THE LEFT COMMON ILIAC. CONTRAST IS THEN SEEN OUTSIDE THE AORTIC NECK NEAR THE LEVEL OF THE BIFURCATE AORTIC BODY. IMAGES DURING BALLOONING OF THE NECK WERE NOT RETURNED. AN ENDURANT AORTIC CUFF WAS THEN SEEN IMPLANTED NEAR THE LEVEL OF THE BIFURCATE, FOLLOWED BY BALLOONING WITHIN THE AORTIC BODY. THE PERFORATION APPEARED TO HAVE RESOLVED, HOWEVER, AFTER REMOVAL OF THE BALLOON THE AORTIC BODY AND BOTH LIMBS APPEARED OCCLUDED. THE CONTRA LIMB WAS COMPLETELY OCCLUDED AND THE IPSI LIMB WAS PARTIALLY OCCLUDED. FOLLOWING BALLOONING AND THROMBECTOMY WITHIN THE DEVICES THE OCCLUSION/THROMBUS APPEARED TO HAVE RESOLVED. THE CAUSE OF THE AORTIC NECK PERFORATION IS UNKNOWN; MAY BE DUE TO MODELING WITHIN THE SEVERELY CALCIFIED NECK. THE CAUSE OF THE OCCLUSION MAY BE DUE TO THE PROLONGED BALLOONING WITHIN THE AORTIC BODY TO ACHIEVE HEMOSTASIS, AND POSSIBLY ALSO DUE TO A PATIENT CONDITION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682200 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04222217

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death| R