BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3813138 · Received May 15, 2014

    Report

    Report Number
    2953200-2014-00988
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES, CONCLUSION: OFF-LABEL, UNAPPROVED OR CONTRAINDICATED USE (STENT GRAFT WAS IMPLANT IN A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY IMPLANTED WITH ANOTHER MANUFACTURER¿S STENT GRAFT AND PRESENTED IN THE ER WITH ANEURYSM RUPTURE. THE PHYSICIAN SUSPECTED A TYPE IB ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY. THE PLAN WAS TO COIL EMBOLIZE THE LEFT HYPOGASTRIC ARTERY AND RELINE THE LEFT LIMB OF THE OTHER MANUFACTURER¿S STENT GRAFT WITH A 1610156 ENDURANT SUBSEQUENT TO THE COIL EMBOLIZATION. THE PATIENT WAS ON THE TABLE WITH A 12 FR SHEATH IN THE LEFT COMMON FEMORAL AND ANOTHER MANUFACTURER¿S BALLOON THAT WAS PLACED AT THE LEVEL OF THE FLOW DIVIDER ON THE STENT GRAFT TO STOP BLOOD FROM LEAKING. THE COIL EMBOLIZATION WAS COMPLETED AND PLACEMENT OF THE 1610 ENDURANT LIMB WAS COMPLETED WITHOUT COMPLICATION. THE DEVICE WAS REMOVED WITHOUT ISSUE AND BACK PLUGGED WITH A 12 FR SHEATH. THE PHYSICIAN ALSO NOTED THAT THE DISTAL RCIA WAS ECTATIC/ANEURYSMAL BEYOND THE LEVEL OF THE EXISTING LIMB ON THIS SIDE. TO ELIMINATE THIS AS A POTENTIAL CURRENT/FUTURE ISSUE, THE PHYSICIAN DECIDED TO PLACE A 16X24X93 LIMB ON THE PATIENT¿S RIGHT COMMON ILIAC TO GET COVERAGE ALL THE WAY TO THE RIGHT HYPOGASTRIC ARTERY. THIS DEVICE WAS PLACED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT COMPLICATION. DURING THE PROCEDURE, PRE-PROCEDURE AND DURING THE REPAIR OF THE FEMORAL ARTERIES THE PATIENT WAS GIVEN BLOOD PRODUCTS (VOLUME NOT KNOWN). THE PHYSICIAN STATED THAT THE ABDOMEN WAS GETTING HARD AND FELT THAT IT WAS NECESSARY TO DO A MIDLINE INCISION TO RELIVE WHAT WAS THOUGHT MIGHT BE COMPARTMENT SYNDROME. DURING THIS MANEUVER, THE PHYSICIAN NOTICED FRESH BLOOD AND CONTINUED HIS EXPLORATION. HE NOTED THAT THERE WAS BLOOD LEAKING FROM THE OTHER MANUFACTURER¿S STENT GRAFT IN THE SUTURE SEGMENT WHERE THE SUPRA RENAL STENTS WERE SEWN TO THE GRAFT. THE PHYSICIAN BELIEVES THERE MAY HAVE BEEN AN ISSUE WITH LEAKING IN THE MAIN BODY OF THE STENT GRAFT WHICH WAS NOT AN AREA THAT WAS RELINED DURING THE PROCEDURE. THE PATIENTS BP CONTINUED TO DROP AND THEY WERE UNABLE TO MAINTAIN PRESSURE AND THE PATIENT EXPIRED LATER IN THE EVENING. THE PHYSICIAN DID NOT FEEL THAT THERE WERE ANY ISSUES WITH THE MEDTRONIC STENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291288 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04032615

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death