BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2884187 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02484
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM); INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OVER 10 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM THAT HAD INCREASED IN DIAMETER TO 10CM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK MEASURED 32-33 MM IN DIAMETER. A CT REVEALED STENT GRAFT MIGRATION OF NECK 4CM BELOW THE RENAL ARTERIES WITH A PROXIMAL TYPE I ENDOLEAK NOTED. THE STENT GRAFT MIGRATION AND ENDOLEAK WERE ATTRIBUTED TO DISEASE PROGRESSION. THE PATIENT ALSO HAD A RIGHT COMMON ILIAC ANEURYSM THAT WAS 5CM IN DIAMETER AND A LEFT COMMON ILIAC ANEURYSM THAT WAS 3.5 - 4 CM IN DIAMETER. THE PHYSICIAN REPAIRED THE MIGRATION AND ENDOLEAK WITH AN ENDURANT CUFF (B)(4), AN (B)(4) AND AN (B)(4). THE ILIAC ANEURYSMS WERE TREATED WITH AN (B)(4) AND AN (B)(4) ON THE RIGHT AND AN (B)(4) ON THE LEFT WHICH WAS THE CONTRALATERAL SIDE. THE PHYSICIAN BLOCKED OFF RIGHT BELOW THE FLOW DIVIDER AND PERFORMED A FEM-FEM BYPASS. THE PATIENT WAS ON A VENTILATOR. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01143463

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death