BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3062028 · Received April 16, 2013

    Report

    Report Number
    2953200-2013-00706
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (COAGULATION DISORDER); UNAPPROVED USE OF DEVICE (PRE-OPERATIVE RUPTURE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (COAGULATION DISORDER); KNOWN INHERENT RISK OF A PROCEDURE (OCCLUSION); OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT IMAGING DONE APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE REVEALED THROMBUS FORMATION ON THE LEFT SIDE OF THE STENT GRAFT JUST BELOW THE GATE MARKER. THERE WERE NO OUTFLOW PROBLEMS AND THE PULSES WERE GOOD. THERE WAS NO EVIDENCE OF STENT GRAFT KINKING OR FOLDING. THE PHYSICIAN RE-LINED THE STENT GRAFT WITH AN ENDURANT 16X16X124, MODELED WITH A BALLOON, AND PLACED THE PATIENT ON ANTICOAGULATION THERAPY. HOWEVER, THE PATIENT HAS CLOTTING ISSUES AND NOT ENOUGH HEPARIN COULD BE GIVEN TO FULLY RESOLVE THE CLOTTING. THE PHYSICIAN NOTED THE EVENT TO BE NOT STENT GRAFT RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS POST-IMPLANT SHOWED THAT THE CONTRALATERAL (LEFT) LIMB WAS OCCLUDED BEGINNING AS A THIN LAYER OF THROMBUS JUST ABOVE THE GATE, AND THEN BECOMING NEARLY FULLY OCCLUDED AT THE LIMB MID-LENGTH. WITHIN THE COMMON ILIAC THE FLOW FULLY RETURNED. A STENT WAS SEEN PLACED WITHIN THE LEFT EXTERNAL ILIAC ARTERY. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. THE STENT GRAFT WAS NOT COMPRESSED OR KINKED, AND MEASURED 17MM ID IN THE OCCLUDED SECTION. THE IPSILATERAL LIMB WAS PATENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163513 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC GALWAY V00954757

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention