BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 7051955 · Received November 22, 2017

    Report

    Report Number
    2953200-2017-01838
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    April 4, 2017
    Report Date
    November 22, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; CLINICAL OUTCOMES OF HYPOGASTRIC ARTERY OCCLUSION FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR WUTTICHAI SAENGPRAKAI, JOOST A. VAN HERWAARDEN, GEORGE S. GEORGIADIS, WORAWONG SLISATKORN <(>&<)> FRANS L. MOLL . MINIMALLY INVASIVE THERAPY <(>&<)> ALLIED TECHNOLOGIES, 26:6, 362-371 HTTP://DX.DOI.ORG/10.1080/13645706.2017.1326385.

    Description of Event or Problem · 1

    AN ENDURANT AND TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM, ILIAC ANEURYSM, OR RUPTURED ILIAC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: CLAUDICATION, INCREASE IN ANEURYSM SAC SIZE, ABDOMINAL DISTENSION, LEFT RETRO PELVIC HEMATOMA. ABSTRACT PURPOSE: TO DETERMINE THE MIDTERM OUTCOMES OF INTERNAL ILIAC ARTERY (IIA) COVERAGE BY A STENT GRAFT IN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) UNDER SPECIFIC ANATOMIC AND TECHNICAL CIRCUMSTANCES. MATERIAL AND METHODS: FROM JANUARY 2003 UNTIL JANUARY 2014, 57 PATIENTS WITH AORTOILIAC ANEURYSMS, INCLUDING 20 WITH 24 IIA ANEURYSMS (IIAAS), UNDERWENT EVAR WITH IIA COVERAGE. IIAA DIAMETER CHANGE OR IIA THROMBOSIS, BUTTOCK CLAUDICATION, TYPE II ENDOLEAK, AND SECONDARY INTERVENTIONS RELATED TO THE IIA WERE STUDIED. RESULTS: TWENTY-FIVE OF THE 37 PATIENTS WITHOUT IIAA WERE EMBOLIZED PRIOR TO STENT-GRAFT PLACEMENT, ALL UNILATERAL, AND IN 12, THE IAA ORIFICE WAS ONLY OVER-STENTED. BUTTOCK CLAUDICATION OCCURRED IN ONLY NINE (20%) OF THE EMBOLIZATION PATIENTS (9/49 IIA¿S) (P¼.14), WHILE ONE IIA RELATED TYPE II ENDOLEAK, OCCURRED IN THE NON-EMBOLIZATION GROUP (P¼.16). IN PATIENTS WITH IIAA(S), THE ANEURYSM DIAMETER DECREASED IN 16 CASES (67%). BUTTOCK CLAUDICATION OCCURRED IN 75% OF BILATERAL, AND IN 14.6% OF UNILATERAL EMBOLIZATION (P¼.046). CONCLUSIONS: CAREFULLY SELECTED PATIENTS WITH AORTOILIAC ANEURYSM WITHOUT IIAA MAY SAFELY UNDERGO HYPOGASTRIC ARTERY OVER-STENTING WITHOUT PREEMPTIVE EMBOLIZATION DURING EVAR. IIA EMBOLIZATION IS ASSOCIATED WITH BUTTOCK CLAUDICATION AND SHOULD BE AVOIDED IF POSSIBLE. OTHERWISE, AT LEAST ONE IIA SHOULD BE PRESERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831186 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention