BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3031565 · Received April 2, 2013

    Report

    Report Number
    2953200-2013-00593
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    May 11, 2011
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: (FILMS).

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK, MORPHOLOGY CHANGES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK, MORPHOLOGY CHANGES).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 YEAR FOLLOW-UP IMAGING REVEALED A SEPARATION BETWEEN THE IPSILATERAL LIMB 162495 AND THE BIFURCATED STENT GRAFT IN THE COMMON ILIAC ARTERY. THE PHYSICIAN BELIEVES A PERSISTENT TYPE II ENDOLEAK CAUSED A CHANGE IN THE PRESSURE DYNAMICS OF THE ANEURYSM SAC WHICH CAUSED THE STENT GRAFTS TO SEPARATE. AN ENDURANT 202080 WAS IMPLANTED SIX DAYS LATER COVERING THE SEPARATION AND RESOLVING THE TYPE III ENDOLEAK. TWO X-RAY IMAGES WERE REVIEWED AND SHOWED THE IPSILATERAL EXTENSION WAS OVERLAPPING THE BIFURCATE IPSILATERAL LIMB BY APPROXIMATELY 2-3 STENT RINGS (PER THE MARKERS). THE IPSILATERAL LIMB WAS RELATIVELY STRAIGHT ALONG ITS LENGTH. AN X-RAY FROM APPROXIMATELY SIX WEEKS AGO SHOWS THERE IS NO OVERLAPPING BETWEEN THE IPSILATERAL LIMB AND EXTENSION (MARKERS ARE NEARLY ALIGNED). THE ORIGIN OF THE IPSILATERAL LIMB IS MORE ANGULATED COMPARED TO THE PREVIOUS IMAGE. ASSESSMENT OF THE ENDOLEAK AND THE AMOUNT OF DISTAL SEALING IN THE RIGHT ILIAC COULD NOT BE PERFORMED. THE CAUSE OF THE SEPARATION IS UNKNOWN. IT IS POSSIBLE THAT ANEURYSM MORPHOLOGY CHANGES, IN COMBINATION WITH LACK OF DIAMETER OVERSIZING BETWEEN THE TWO LIMBS, MAY HAVE CONTRIBUTED TO THE SEPARATION.

    Description of Event or Problem · 1

    ADDITIONAL POST-IMPLANT FILMS WERE RECEIVED FROM THE 4-MONTHS FOLLOW-UP ON THE BIFURCATE WAS SEEN POSITIONED JUST BELOW THE RENAL ARTERIES. THERE IS A POSSIBLE PROXIMAL TYPE I ENDOLEAK. FOLLOWING THE IMPLANT OF A PALMAZ STENT IMPLANTED WITHIN THE ENDURANT AORTIC BODY, THE ENDOLEAK APPEARS TO HAVE RESOLVED. THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS UNKNOWN. THE IPSILATERAL LIMB IS ON THE RIGHT SIDE, AND AN EXTENSION IS SEEN OVERLAPPING THE LIMB BY APPROXIMATELY 3.5CM (PER THE MARKERS). THE IPSILATERAL LIMB IS ESSENTIALLY STRAIGHT IN THIS IMAGE. NO ENDOLEAK OR ANY STENT GRAFT ISSUES WERE OBSERVED ON FINAL ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134677 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00389253

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention