BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 5100717 · Received September 24, 2015

    Report

    Report Number
    2953200-2015-01621
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 29, 2015
    Report Date
    October 2, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PRE-IMPLANT 3D FILM REPORT REVEALED THAT THE PATIENT HAD A SEVERELY ANGULATED PROXIMAL NECK. BOTH THE INFRARENAL AND SUPRARENAL NECK ANGULATION APPEARED TO BE BETWEEN 60 ¿ 90 DEG. THE NECK DIAMETER JUST BELOW THE RENALS MEASURED 24 ¿ 25MM, 9MM LOWER WAS 27MM IN DIAMETER, AND 17MM LOWER AT THE BOTTOM OF THE NECK WAS 27 ¿ 28MM IN DIAMETER. THE NECK WAS ALSO EXTENSIVELY CALCIFIED. THE MAX AAA DIAMETER WAS 52MM AND THE DISTAL AORTIC DIAMETER WAS 22MM. THE ILIAC ARTERIES WERE EXTENSIVELY CALCIFIED BILATERALLY. THE EXACT CAUSE OF THE REPORTED PROXIMAL TYPE I ENDOLEAK SEEN AT IMPLANT, AND THE PATIENT DEATH OCCURRING DURING EXPLANT OF THE STENT GRAFTS COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. IMAGES DURING AND POST-IMPLANT WERE NOT AVAILABLE FOR REVIEW, AND ANY ASSESSMENT OF THE IMPLANTED APTUS ENDOANCHORS ALSO COULD NOT BE PERFORMED. IT IS POSSIBLE THAT THE SHORT, ANGULATED, AND CALCIFIED PROXIMAL NECK MAY HAVE CONTRIBUTED TO THE PROXIMAL TYPE I ENDOLEAK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED 5.2MM IN DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 25-27MM IN DIAMETER AND 17MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 11-10-14MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 07-18-13MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 5.9MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 6.3MM IN DIAMETER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS FOUND. THE PHYSICIAN INTERVENED AND IMPLANTED 20 APTUS ENDOANCHORS HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN STATED THAT THE CAUSE OF THE TYPE I ENDOLEAK WAS DUE TO THE PATIENT'S SHORT CONICAL AND MODERATELY ANGLED AORTIC NECK. THE PATIENT WAS DISCHARGED AND PRESENTED TWO WEEKS LATER TO ANOTHER HOSPITAL. THE PATIENT WAS CONVERTED TO OPEN REPAIR DUE TO THE TYPE IA ENDOLEAK AND TO HAVE THE STENT GRAFTS EXPLANTED HOWEVER, THE PATIENT DID NOT SURVIVE THE PROCEDURE. PER THE PHYSICIAN'S STATEMENT THE CAUSE OF DEATH WAS DUE TO HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630713 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF3214C103E

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death| R