BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2781530 · Received October 10, 2012

    Report

    Report Number
    2953200-2012-01935
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, TRAUMA TO THE VESSEL), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (THIN FRAIL VESSELS AND TYPE II ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (THIN FRAIL VESSELS AND TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK WAS 25 MM IN DIAMETER, THEN THERE WAS AN ACCESSORY RENAL ARTERY WITH AN ANTERIOR TAKE OFF, THEN THE AORTIC NECK WAS 29 MM IN DIAMETER AND JUST ABOVE THE ANEURYSM IT WAS 26 MM WITH A LENGTH OF 25 MM. THE LEFT ILIAC ARTERY MEASURED 23 MM IN DIAMETER AND THE RIGHT ILIAC ARTERY MEASURED 35MM AND 25MM IN DIAMETER. THE LENGTH OF THE LEFT ILIAC ARTERY MEASURED 45MM AND THE LENGTH OF THE RIGHT ILIAC ARTERY MEASURED 50MM. TORTUOUS ACCESS VESSELS MADE EVERYTHING DIFFICULT. AN UNSUCCESSFUL ATTEMPT WAS MADE TO COIL THE LEFT INTERNAL ILIAC THAT TOOK 2 TO 3 HOURS. THE DECISION WAS MADE TO PROCEED WITHOUT COILING. THERE WERE SIX STENT GRAFTS IMPLANTED. IT WAS REPORTED THAT AFTER THE STENT GRAFT PLACEMENT AND MODELING WITH A RELIANT BALLOON A FINAL ANGIOGRAM REVEALED A TYPE II ENDOLEAK, BUT NO OTHER LEAKS OR AREAS OF CONCERN. THE PATIENT LEFT THE OR AND WENT TO RECOVERY WITH A NORMAL BLOOD PRESSURE. A COUPLE HOURS LATER THE PATIENT HAD A SUDDEN LOSS OF BLOOD PRESSURE AND STARTED SHOWING OTHER CONCERNING VITAL SIGNS. A CT WAS ORDERED BUT THE PATIENT WAS JUDGED TO BE TOO UNSTABLE FOR A CT SCAN AND BROUGHT BACK TO THE OR. UPON OPENING THE ABDOMEN A LARGE AMOUNT OF BLOOD WAS OBSERVED AND A RUPTURED RIGHT COMMON ILIAC WAS FOUND. THE STENT GRAFTS WERE VISIBLE THROUGH THE RUPTURE AND BLOOD WAS FLOWING PAST THE DISTAL END OF THE GRAFT AND OUT THE RUPTURE. ATTEMPTS WERE MADE TO REPAIR THE RUPTURE BUT THE ARTERY WAS VERY THIN AND DID NOT HOLD THE SUTURE. LARGE AMOUNTS OF BLOOD WERE GIVEN. THE BLEEDING COULD NOT BE STOPPED AND THE PATIENT WAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01101061

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Death