BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3160199 · Received June 10, 2013

    Report

    Report Number
    2953200-2013-01091
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 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). RESULTS: ENDOLEAK. ANATOMY RELATED; NECK CONTAINED THROMBUS, AND WAS CONICAL SHAPED. CONCLUSION: ENDOLEAK. ANATOMY RELATED; NECK CONTAINED THROMBUS, AND WAS CONICAL SHAPED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60X56 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 25 MM IN DIAMETER. THE PATIENT HAD THROMBUS IN THE PROXIMAL NECK. IT WAS REPORTED THAT INTRA-OPERATIVELY, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. THE PHYSICIAN IMPLANTED AN ENDURANT CUFF JUST BELOW THE RENAL ARTERIES, HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN THOUGHT THE LEAK WOULD SELF-RESOLVE AND FINISHED THE PROCEDURE. THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. THE PHYSICIAN STATED THERE WAS THE POSSIBILITY THAT THE PROXIMAL SEALING WAS NOT STABLE DUE TO THROMBUS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF CASE DRAWING SHOWED A CONICAL NECK (21-29MM DIAMETER), WHICH WAS MODERATELY ANGULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261041 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04024123

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention