BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1990330 · Received February 9, 2011

    Report

    Report Number
    2953200-2011-00306
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    January 3, 2021
    Report Date
    January 10, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: OCCLUSION, DEATH. SEVERE ILIAC TORTUOSITY BILATERALLY AND 50 PERCENT OF CIRCUMFERENTIAL THROMBUS. CONCLUSION: SEVERE ILIAC TORTUOSITY BILATERALLY AND 50 PERCENT OF CIRCUMFERENTIAL THROMBUS.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 6.5 CM FUSIFORM ABDOMINAL AORTIC ANEURYSM NINE MONTHS AGO. THE VESSEL MORPHOLOGY WAS REPORTED AS THE INFRARENAL AORTIC ANGLE WAS 43 DEGREES. AORTIC NECK WAS 17-18 MM IN DIAMETER, DISTAL AORTA WAS 19 MM IN DIAMETER AND 27 MM LONG WITH 50% CIRCUMFERENTIAL THROMBUS. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS AND 12-15 MM IN DIAMETER ON THE RIGHT AND 13-15 MM IN DIAMETER ON THE LEFT. IT WAS REPORTED THAT DURING DEPLOYMENT, GRAFT COVERED BOTH INTERNAL ILIAC ARTERIES UNINTENTIONALLY, SPECIFICALLY, THE LEFT ILIAC ARTERY. IT WAS REPORTED THAT TEN DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND THE PATIENT WAS HOSPITALIZED, AS THE EVENT IS CONTINUING. THE INVESTIGATOR'S ASSESSMENT STATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE; HOWEVER, WAS RELATED TO THE STUDY PROCEDURE. EIGHT MONTHS POST STENT GRAFT IMPLANT, THE PATIENT WAS HOSPITALIZED DUE TO A URINARY TRACT INFECTION. IT WAS REPORTED ONE WEEK LATER, THE PATIENT EXPIRED AT HOME OF UNKNOWN CAUSE. THE INVESTIGATOR ASSESSED THAT THE DEATH WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00338296

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death