BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 8050310 · Received November 8, 2018

    Report

    Report Number
    2953200-2018-01565
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    June 1, 2016
    Report Date
    January 10, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; A TECHNIQUE OF ¿CHIMNEY NELLIX¿ FOR THE MANAGEMENT OF TYPE 1A ENDOLEAK AFTER EVAR. J VASC INTERV RADIOL 2018; 29:623¿627 SIMON Z. JOSEPH, MBBS(HON), C.H. RICKY KWOK, MBCHB, JOSEPH A. HOCKLEY, MBBS, MAREK W. GARBOWSKI, MD, JOHN FERGUSON, MBCHB, SHAUN SAMUELSON, MD, AND SHIRLEY J. JANSEN, PHD HTTPS://DOI.ORG/10.1016/J.JVIR.2017.10.022 CONTINUATION FROM EXACT EVENT DATE UNKNOWN - YEAR VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FDC CODE ADDED AT INVESTIGATION COMPLETION. 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 THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED INFRARENAL ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE IT WAS NOTED THAT THE ILIAC VESSEL SIZE WAS INADEQUATE TO ALLOW ACCESS FOR THE MAIN BODY OF AVAILABLE FENESTRATED DEVICES AND SO A 2-VESSEL TECHNIQUE WAS PLANNED. IT WAS REPORTED, 9 MONTHS POST IMPLANT, THE PATIENT EXPERIENCED A TYPE IA ENDOLEAK. A CHEVAR PROCEDURE WAS THEN CARRIED OUT TO TREAT THIS EVENT WITH THE INJECTION OF A SECONDARY POLYMER INTO THE LEFT STENT¿S ENDOBAG RESOLVING THIS. DURING THE CHEVAR PROCEDURE, IT WAS REPORTED THE PATIENT HAD DISSECTIONS OF THE LEFT SUBCLAVIAN ARTERY, WHICH REQUIRED TREATMENT WITH A ZILVER PTX (COOK MEDICAL) DRUG ELUTING STENT AT THE TIME OF THE PROCEDURE. IT WAS REPORTED THE PATIENT EXPERIENCED POSTOPERATIVE HYPOTENSION ASSOCIATED WITH LEFT FLANK PAIN WHILE IN RECOVERY. CT ANGIOGRAPHY REVEALED A LEFTSIDED HEMATOMA AND A CFA PSEUDOANEURYSM WITH RETROPERITONEAL BLEED, WHICH SPONTANEOUSLY THROMBOSED ON FOLLOW-UP ULTRASOUND IMAGING A FEW HOURS LATER. FOLLOW-UP CT ANGIOGRAPHY AT 10 MONTHS AFTER THE PROCEDURE SHOWED STABLE ANEURYSM SAC SIZE, PATENCY OF THE NELLIX AND VISCERAL STENTS, AND NO RESIDUAL TYPE 1A ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891010 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention