BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3140252 · Received May 31, 2013

    Report

    Report Number
    2953200-2013-01036
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILMS. RESULTS: ENDOLEAK. ANATOMY RELATED; DISEASE PROGRESSION. CONCLUSION: ANATOMY RELATED; DISEASE PROGRESSION.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN 8.7 IN DIAMETER X 8.3 CM IN LENGTH AND 5.2 CM IN DIAMETER AND 4.3 CM IN LENGTH (SNOWMAN SHAPE) ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK WAS 30 MM IN DIAMETER AND THE ILIAC LIMB DISTAL DIAMETER WAS 15 MM ON THE RIGHT AND 13 MM IN DIAMETER ON THE LEFT. IT WAS REPORTED THAT THERE WAS CONTINUED DISEASE PROGRESSION IN THE ILIAC LIMBS. THE PATIENT WAS NOT A GOOD EVAR CANDIDATE AT THE TIME OF IMPLANT, BUT WAS NOT A CANDIDATE FOR OPEN SURGERY SO EVAR WAS ATTEMPTED AND THE PHYSICIAN STATED THAT THERE WERE EXCELLENT FINAL ANGIOGRAM RESULTS. IT WAS REPORTED THAT THE PATIENT RECENTLY PRESENTED EMERGENTLY WITH SEVERE BACK PAIN. THE CT SCAN REVEALED AN UNKNOWN ENDOLEAK HOWEVER UNDER FLUOROSCOPY IT REVEALED THAT THERE WAS A TYPE III ENDOLEAK, SEPARATION, LIMB DISUNION AND A DISTAL TYPE 1 ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X16X82 CONTRALATERAL LIMB ON THE RIGHT AND AN ENDURANT 16X20X124 ON THE LEFT SIDE SUCCESSFULLY RESOLVING THE ENDOLEAKS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF SEVERAL POST-IMPLANT STILL ANGIOGRAM IMAGES (FLAT FILMS). THE ASSESSMENT WAS LIMITED DUE TO THE LACK OF PATIENT ORIENTATION AND LOW RESOLUTION. THE FILMS CONFIRMED A LIKELY TYPE III SEPARATION ENDOLEAK ON THE LEFT SIDE OF THE IMAGE, WITHIN THE AAA. THE DISTAL TYPE I ENDOLEAK COULD NOT BE CONFIRMED. FOLLOWING INTERVENTION THERE APPEARED TO BE RESOLUTION OF THE TYPE III ENDOLEAK. THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242034 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention