BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT WITH XPEDIENT

    MDR report key: 1982502 · Received February 3, 2011

    Report

    Report Number
    2953200-2011-00248
    Event Type
    Death
    Date Received
    February 3, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: MIGRATION, ENDOLEAK, RUPTURED ANEURYSM, HEMORRHAGE, DEATH. DISEASE PROGRESSION, DEVICE WAS USED FOR TREATMENT OF A PRE-OPERATIVE RUPTURED ANEURYSM, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSELS.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 9.5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT FIVE YEARS POST STENT GRAFT IMPLANT, THE ABDOMINAL AORTIC ANEURYSM DIAMETER WAS 6.4CM, AND THE AORTIC NECK WAS ANGULATED 25 DEGREES, 18 MM IN DIAMETER AT THE RENAL ARTERIES AND 20 MM IN DIAMETER 1 CM BELOW, WITH NO THROMBUS, MILD CALCIFICATION, AND MODERATE TORTUOSITY. THE ILIAC ARTERIES WERE MODERATELY CALCIFIED AND MODERATELY TORTUOUS. AN ANEURX BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED SUCCESSFULLY. IT WAS REPORTED 37 MONTHS POST INITIAL IMPLANT, A 26X37.5 ANEURX AORTIC EXTENSION WAS IMPLANTED TO TREAT AN ANEURYSM RUPTURE (REF MFR #2953200-2011-00246). IT WAS REPORTED THAT 21 MONTHS LATER, THE PT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK, DUE TO A 20 MM DISTAL MIGRATION OF THE ANEURX BIFURCATED STENT GRAFT WHICH WAS ATTRIBUTED TO THE ANGULATED AORTIC NECK. (REF MFR #2953200-2011-00247) THE PT WAS TREATED WITH A TALENT STUDY AORTIC CUFF PLACED PROXIMALLY VIA THE RIGHT SIDE WITH THE BARE SPRINGS CROSSING BOTH RENAL ARTERIES AND WITH AN OVERLAP OF 10 MM WITH THE ANEURX CUFF PREVIOUSLY IMPLANTED. AT THE INTERVENTION, A PROXIMAL TYPE I ENDOLEAK AND A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE ANEURX CUFF AND THE TALENT CUFF WERE NOTED. THE PHYSICIAN IMPLANTED TWO 26X37.5 ANEURX CUFFS (REF MFR # 2953200-2011-00249) TO INTERVENE FOR THESE LEAKS. AT ONE MONTH AND ONE YEAR POST INTERVENTION FOLLOW-UPS, THE ABDOMINAL AORTIC ANEURYSM WAS STABLE AT 6.4 CM AT. APPROXIMATELY ONE MONTH AGO, THE PT PRESENTED WITH ACUTE SEVERE ABDOMINAL PAIN. THE RECENT CT DEMONSTRATED THAT THERE WAS A TYPE III ENDOLEAK, (UNK LOCATION), ABDOMINAL AORTIC RUPTURE AND RETROPERITONEAL HEMORRHAGE. THE INVESTIGATOR ASSESSED THE PT'S DEATH TO BE UNRELATED TO THE DEVICE OR PROCEDURE BUT RELATED TO THE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA 363456

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death