BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 9686143 · Received February 10, 2020

    Report

    Report Number
    9612164-2020-00631
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    December 4, 2019
    Report Date
    March 9, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169439979
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: ETLW1616C93E, SERIAL/LOT #: (B)(4), UBD: 26-AUG-2021, UDI#: (B)(4); PRODUCT ID: ETLW1610C156E, SERIAL/LOT #: (B)(4), UBD: 23-SEP-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DISTAL LEG CLAUDICATION DUE TO PERIPHERAL DISEASE. INTRAVASCULAR ULTRASOUND SHOWED A SMALL KINK IN THE RIGHT LIMB AS COURSED OVER THE RIGHT HYPOGASTRIC AND 65% NARROWING. THE PATIENT WAS ALSO NOTED TO HAVE DISTAL VESSEL DISEASE ALSO. THE PHYSICIAN BALLOONED AND REINFORCED THE ENDOGRAFT LIMB WITH A BARE METAL STENT WITHOUT COMPLICATION AND THE OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE LEG DISCOMFORT POST THE SECONDARY PROCEDURE, HOWEVER, IT IS NOTED THAT THE PATIENT HAS BEEN TREATED FOR CHRONIC PAIN IN THE PAST PRE EVAR. IT WAS CONFIRMED THAT THE PATIENT FIRST RETURNED ON THE (B)(6) 2019 COMPLAINING OF THE SYMPTOMS OF THE DISTAL LEG CLAUDICATION. IT WAS REPORTED THAT ON THE (B)(6) 2019, THE PATIENT HAD A ANKLE-BRACHIAL INDEX (ABI) ON THE RIGHT OF .89 AND ON THE (B)(6) 2019 HAD A ABI OF .77. ON THE (B)(6) 2019, THE PATIENT HAD A DIAGNOSTIC ANGIOGRAM WHERE INTRAVASCULAR ULTRASOUND SHOWED A 51.4% NARROWING. DURING THE PROCEDURE THE PHYSICIAN USED SEQUENTIAL 9X40 AND 10X40 ANGIOPLASTY BALLOONS AND THEN PLACED A 10X40 SELF EXPANDING STENT. FOLLOW-UP ON THE (B)(6) 2020 SHOWED THE PATIENT HAD A RESTING ABI OF 1.02 AND WITH EXERCISE THE ABI ON THE RIGHT FELL TO 0.9 AND PATIENT EXPRESSED THAT HIS PAIN HAD NOT IMPROVED. IT WAS REPORTED THAT THE PHYSICIAN WAS CONCERNED THAT HIS EMBOLIZATION OF THE RIGHT HYPOGASTRIC MAY BE PROVIDING SOME OF THE CLAUDICATION SYMPTOMS BUT STATED THAT THE PATIENT'S HISTORY OF HAVING NUMEROUS BACK SURGERIES WAS LIKELY THE CAUSE OF THE PATIENTS PAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. THE PATIENT REPORTED VIA TECHNICAL SERVICES THAT HIS STENT GRAFT HAS COLLAPSED AND A SECONDARY PROCEDURE IS PLANNED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152900 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ESBF2814C103E 00643169439979

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention