BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 4811513 · Received June 2, 2015

    Report

    Report Number
    9612164-2015-00870
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CONCLUSION: OFF-LABEL (IMPLANTING FOR A PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVE RUPTURE OF A 15.5 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A CT SCAN REVEALED 15.5CM ABDOMINAL ANEURYSM WITH A RIGHT RETROPERITONEAL HEMATOMA. VITAL SIGNS WERE STABLE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND ENDOVASCULAR AORTIC REPAIR DONE SUCCESSFULLY. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK. THE PHYSICIAN THEN STATED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH BLOODY URINE AND ABDOMINAL PAIN. A CT REVEALED A TYPE 1B ENDOLEAK ON THE RIGHT AND SURGERY WAS PLANNED FOR THAT DAY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND AN ANGIOGRAM CONFIRMED A TYPE 1B. THE RIGHT COMMON ILIAC ARTERY WAS EXTREMELY SHORT AND DUE TO THE SIZE OF THE ANEURYSM THE COMMON ILIAC LENGTH WAS DIFFICULT TO ASSESS. THE PHYSICIAN DECIDED TO LAND THE DEVICE IN THE RIGHT EXTERNAL ILIAC ARTERY AND AN ENDURANT II 16X10X199 WAS IMPLANTED. THE RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY OCCLUDED BECAUSE THERE WAS NO ILIAC ARTERY DUE TO THE SIZE OF THE ANEURYSM. THERE WAS NO NEED TO EMBOLIZE THE PATIENT OR RE-IMPLANT AS THE DEVICE COVERED IT COMPLETELY. THE PATIENT IS WITHOUT PELVIC ISCHEMIA. THE ENDOLEAK WAS RESOLVED AND THE PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION. PER THE PHYSICIAN, THE CAUSE OF DISTAL TYPE I ENDOLEAK WAS DUE TO A SHORT ILIAC ARTERY LANDING ZONE CAUSED BY THE LARGE SIZE OF THE ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354228 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1624C124E

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention