BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 7241111 · Received February 5, 2018

    Report

    Report Number
    2953200-2018-00187
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    December 11, 2017
    Report Date
    February 5, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; TRIPLE IN SITU ANTEGRADE LASER FENESTRATION OF AORTIC STENT-GRAFT EXTENSION USING FUSION IMAGING FOR URGENT TREATMENT OF SYMPTOMATIC ABDOMINAL ANEURYSM WITH TYPE 1 ENDOLEAK JOSEPH TOUMA, HICHAM KOBEITER, MAREK MAJEWSKI, VANIA TACHER, PASCAL DESGRANGES HTTPS://DOI.ORG/10.1007/S00270-017-1837-4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED IN A PATIENT. THE FOLLOWING ADVERSE EVENT WAS REPORTED: PROXIMAL TYPE 1 ENDOLEAK WITH AN ENLARGED SYMPTOMATIC ANEURYSMAL SAC. URGENT TREATMENT WAS PERFORMED USING IN SITU LASER FENESTRATION OF AN AORTIC PROXIMAL EXTENSION FACING RENO-VISCERAL OSTIA. FINAL ANGIOGRAM DEMONSTRATED ANEURYSM EXCLUSION AND PATENT TARGET VESSELS. THE POSTOPERATIVE COURSE AND 7 MONTHS FOLLOW-UP WERE UNEVENTFUL. NO OTHER CLINICAL SEQUELAE WERE REPORTED. ABSTRACT THE PRESENT REPORT DESCRIBES THE MANAGEMENT OF MASSIVE PROXIMAL TYPE 1 ENDOLEAK WITH AN ENLARGED SYMPTOMATIC ANEURYSMAL SAC. URGENT TREATMENT WAS PERFORMED USING IN SITU LASER FENESTRATION OF AN AORTIC PROXIMAL EXTENSION FACING RENOVISCERAL OSTIA. IMAGE FUSION WAS OBTAINED INTRAOPERATIVELY. FOR EACH TARGET VESSEL (SUPERIOR MESENTERIC AND TWO RENAL ARTERIES), AN APTUS HELIFX STEERABLE SHEATH (MEDTRONIC) INSERTED THROUGH FEMORAL ACCESS WAS CURVED TO FACE THE VESSEL¿S OSTIUM MARKER. A LASER CATHETER (SPECTRANETICS) WAS USED TO TRAVERSE THE STENTGRAFT AND INSERT A 0.014¿¿ GUIDEWIRE IN THE VESSEL. THE FENESTRATION WAS ENLARGED USING A 2.5-MM-DIAMETER CUTTING BALLOON, FOLLOWED BY A 4-MM-DIAMETER BALLOON ANGIOPLASTY AND A V12 I CAST/ADVANTA COVERED STENT IMPLANTATION. FINAL ANGIOGRAM DEMONSTRATED ANEURYSM EXCLUSION AND PATENT TARGET VESSELS. THE POSTOPERATIVE COURSE AND 7 MONTHS FOLLOW-UP WERE UNEVENTFUL. MEDICAL HISTORY; SEVERE CORONARY DISEASE, ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86071 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention