BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II BIFURCATED STENT GRAFT

    MDR report key: 9081470 · Received September 18, 2019

    Report

    Report Number
    9612164-2019-03967
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00613994991041
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ETLW1616C93E, SERIAL/LOT #: (B)(4), UBD: 01-SEP-2017, UDI #: (B)(4); PRODUCT ID: ETLW1616C124E, SERIAL/LOT #: (B)(4), UBD: 02-SEP-2017, UDI #: (B)(4); PRODUCT ID: ETLW1616C82E, SERIAL/LOT #: (B)(4), UBD: 14-SEP-2017, UDI #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II AORTIC CUFF WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. THE CURRENT PROXIMAL AORTIC NECK DIAMETER MEASURES 32 MM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. CT IDENTIFIED AN ENLARGING AAA AND A SUSPECTED TYPE IA/IB ENDOLEAK. INTERVENTION WAS COMPLETED AND THE PHYSICIAN ELECTED TO IMPLANT A 36 MM AORTIC CUFF, 5 ENDOANCHORS AND A 20 MM LIMB EXTENSION TO THE RCI WITH RESOLUTION OF THE ENDOLEAK CONFIRMED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874686 ENDURANT II BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETBF3616C166E 00613994991041

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention