BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3080758 · Received April 26, 2013

    Report

    Report Number
    2953200-2013-00777
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    July 10, 2010
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHODS: (FILM); RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, BLOOD LOSS, AMPUTATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED); CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 3.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS 20 DEGREE AORTIC NECK ANGULATION, THE AORTIC NECK WAS 20 MM IN DIAMETER PROXIMALLY AND THE DISTAL DIAMETER IS 20 MM. THERE WAS MILD ILIAC TORTUOSITY BILATERALLY AND A SHARP BEND AT DISTAL END ILIAC ARTERY. IT WAS REPORTED THAT THERE WAS SEROMA AND STENOSIS IN THE LEFT SIDE. THREE MONTHS LATER, THE PHYSICIAN TREATED THE PATIENT AND THE OCCLUSION WAS RESOLVED. THE INVESTIGATOR ASSESSED THERE WAS WOUND COMPLICATIONS WAS RELATED TO THE INDEX PROCEDURE. THE ONE YEAR CT REVEALED THAT THE ABDOMINAL AORTIC ANEURYSM IS 3.7 CM IN DIAMETER AND STENT GRAFT OCCLUSION IN THE RIGHT ILIAC ARTERY. ONE MONTH LATER ABDOMINAL AORTIC ANEURYSM WAS 3.9 CM IN DIAMETER. THE PATIENT HAD A SECONDARY INTERVENTION TO RESOLVE THE STENOSIS IN THE STENT GRAFT IN THE LEFT STENT GRAFT. THE PHYSICIAN ELECTED TO IMPLANT OF A STENT GRAFT EXTENSION ENEW2020C80EE (RIGHT). THE OCCLUSION WAS RESOLVED. THE INVESTIGATOR ASSESSED THIS TO BE RELATED TO STUDY DEVICE NOT THE PROCEDURE. ONE YEAR LATER, THE CT REVEALED THAT THE ABDOMINAL AORTIC ANEURYSM IS 3.2 CM IN DIAMETER AND THERE WAS STENT GRAFT OCCLUSION IN THE RIGHT ILIAC ARTERY, HOWEVER, THERE WAS NO INTERVENTION PERFORMED. THE THREE YEAR FOLLOW UP CT REVEALED THAT THERE WAS STENT GRAFT STENOSIS, THE INVESTIGATOR INDICATED THAT THE EVENT WAS RELATED TO THE DEVICE. ONE MONTH LATER, THE PATIENT HAD A SECONDARY INTERVENTION TO RESOLVE THE STENOSIS IN THE STENT GRAFT IN THE RIGHT ILIAC STENT GRAFTS. THE ULTRASOUND REVEALED THAT THERE WAS INTERMITTENT CLAUDICATION, STENOSIS IN RIGHT EXTENSION ILIAC EXTENSION. THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFT WITH A BALLOON AND IMPLANTATION OF A STENT GRAFT EXTENSION. IT WAS ALSO REPORTED THAT LATER THAT NIGHT THE PATIENT HAD SEVERE BLOOD LOSS IN THE GROIN AND UNDERWENT RE-SURGERY TO PREVENT FROM FURTHER BLOOD LOSS. THE INVESTIGATOR ASSESSED THAT THE BLEEDING COMPLICATIONS WERE NOT RELATED TO THE DEVICE OR PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILMS WERE REVIEWED. THE FILMS REVEALED THAT THE ENDURANT AORTIC EXTENSION WAS IMPLANTED IN INSIDE OF A THE PREVIOUSLY IMPLANTED EXT ENSION STENT GRAFT, WHICH APPEARED TO NOT HAVE FULLY EXPANDED IN OVERLAPPING STENT GRAFT AREA. VESSEL ANATOMY SHOWS SHARP BEND AT DISTAL END OF EXTENSION WHICH MAY HAVE ALSO CONTRIBUTED TO POOR DISTAL RUNOFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182597 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00348081

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR