BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3000570 · Received March 12, 2013

    Report

    Report Number
    2953200-2013-00439
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, ARTERIAL OCCLUSION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SHORT AND ANGULATED AORTIC NECK). UNAPPROVED USE OF DEVICE (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A SHORT AND ANGULATED AORTIC NECK). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SHORT AND ANGULATED AORTIC NECK). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH A SHORT AND ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 58MM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS ANGULATED 70 DEGREES, IT WAS 22MM IN DIAMETER AND APPROXIMATELY 5MM IN LENGTH. IT WAS REPORTED THAT ON A FINAL DSA, A LARGE TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN IMPLANTED A CUFF; HOWEVER THE ENDOLEAK DID NOT RESOLVE OR DIMINISH. THE PHYSICIAN CONSIDERED IMPLANTING A PALMAZ STENT PROXIMALLY; HOWEVER WAS NOT ABLE TO PERFORM FURTHER TREATMENT DUE TO THE SHORT AORTIC NECK. THE PHYSICIAN DECIDED TO TAKE MONITOR THE PATIENT AND NO FURTHER INTERVENTION WAS PERFORMED. INTRA-OPERATIVELY A TYPE IV ENDOLEAK WAS ALSO OBSERVED. THE TYPE IV WAS A BLUSH FROM THE FLOW-DIVIDER OF THE BIFURCATED STENT GRAFT. IT WAS NOTED THAT TWO DAYS POST IMPLANT ONE OF THE RENAL ARTERIES WAS PARTIALLY OCCLUDED. THE PROXIMAL EDGE OF THE ENDURANT CUFF HAD PARTIALLY COVERED THE RENAL ARTERY. THE PHYSICIAN STATED THAT THE STENT GRAFT WAS IMPLANTED IN A LOCATION WHERE THE AORTIC NECK WAS SEVERELY ANGULATED AND IT WAS MOST LIKELY THAT THE VESSEL MORPHOLOGY MIGHT HAVE CHANGED AFTER THE PROCEDURE AND CAUSED THE OCCLUSION. THE PHYSICIAN DOES NOT SUSPECT THAT THE STENT GRAFT MIGRATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102775 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01694307

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR