BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8681868 · Received June 10, 2019

    Report

    Report Number
    9612164-2019-02243
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    January 1, 2018
    Report Date
    July 5, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM EVALUATION SUMMARY: THE CAUSE OF THE REPORTED HOLE IN THE STENT GRAFT COULD NOT BE DETERMINED FROM THE RETURNED FILMS. THE ANATOMY AT IMPLANT IS UNKNOWN, AND EARLIER POST-IMPLANT CT¿S WERE NOT PROVIDED FOR COMPARISON. IN ADDITION, THERE WERE NO REPORT THAT A HOLE WAS OBSERVED DURING THE EXPLANT, AND THE PRECISE LOCATION OF THE HOLE IS ALSO UNKNOWN. AAA EXPANSION WAS CONFIRMED DURING THE 13 MONTHS BETWEEN (B)(6) 2017 AND (B)(6) 2018 CT¿S; HOWEVER, THE EXACT CAUSE OF THE EXPANSION COULD NOT BE DETERMINED AS NO CLEAR ENDOLEAK WAS OBSERVED ON ANY OF THE RETURNED CT¿S. A MARGINAL PROXIMAL SEAL WITH LACK OF RADIAL APPOSITION ALONG THE ANTERIOR NECK, LIKELY DUE TO DISEASE PROGRESSION, WAS NOTED ON THE CT¿S. IN ADDITION, ~5MM OF SEVERANCE BETWEEN THE BIFURCATE PROXIMAL MARGIN AND TWO (2) OF THE SUPRARENAL STENT DISTAL APICES WAS SEEN ON THE FILMS JUST PRIOR TO EXPLANT, ALONG THE ANTERIOR OF THE BIFURCATE. NO STENT FRACTURES WERE OBSERVED. THE CAUSE OF THE SEVERANCE IS UNKNOWN AND MAY HAVE BEEN DUE TO THE ANGULATED PROXIMAL NECK AND MORPHOLOGY CHANGES. ALTHOUGH NO CLEAR PROXIMAL TYPE I ENDOLEAK WAS SEEN, IT IS POSSIBLE THAT THE AAA WAS STILL BEING PRESSURIZED VIA THE MARGINAL PROXIMAL SEAL. NO TYPE IIIB ENDOLEAK WAS SEEN; HOWEVER, CALCIFICATION WAS OBSERVED PRIMARILY NEAR THE BIFURCATE FLOW DIVIDER WHICH MAY HAVE LED TO FABRIC ABRASION AND A POTENTIAL ENDOLEAK, WHICH MAY HAVE ALSO CONTRIBUTED TO THE AAA EXPANSION. THE EXPLANTED DEVICE WAS DISCARDED; THEREFORE, A COMPREHENSIVE ANALYSIS OF THE EXPLANTED DEVICES COULD NOT BE PERFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: YEAR ONLY VALID. EXPLANT DATE: YEAR ONLY VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2018, THE PHYSICIAN EXPLANTED THE STENT GRAFT, BECAUSE THEY THOUGHT THERE WAS A HOLE IN THE STENT GRAFT MATERIAL. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS A HOLE IN THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477170 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention