BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 4618443 · Received March 19, 2015

    Report

    Report Number
    2953200-2015-00538
    Event Type
    Injury
    Date Received
    March 19, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 26, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: IMPLANTING IN ZONE 1.

    Description of Event or Problem · 1

    AORTIC MORPHOMETRY AT ENDOGRAFT POSITION AS ASSESSED BY 3D IMAGE ANALYSIS AFFECTS RISK OF TYPE I ENDOLEAK FORMATION AFTER TEVAR DROSOS KOTELIS <(>&<)> CAROLIN BRENKE <(>&<)> STEFAN WÖRZ <(>&<)> FABIAN RENGIER <(>&<)> KARL ROHR <(>&<)> HANS-ULRICH KAUCZOR <(>&<)> DITTMAR BÖCKLER <(>&<)> HENDRIK VON TENGG-KOBLIGK DOI 10.1007/S00423-015-1291-1. ON UNKNOWN DATES BETWEEN 2001 AND 2010, UNKNOWN VALIANT, TALENT TAA STENT GRAFTS WERE IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: OCCLUSION, VESSEL COVERAGE BY STENT GRAFT (INTENTIONAL), VASCULAR BYPASS/CONVERSION, TYPE IA ENDOLEAK, LEAK, TYPE I DISTAL. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. PURPOSE THE PURPOSE OF THIS STUDY WAS TO IDENTIFY MORPHOLOGIC FACTORS AFFECTING TYPE I ENDOLEAK FORMATION AND BIRDBEAK CONFIGURATION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). METHODS COMPUTED TOMOGRAPHY (CT) DATA OF 57 PATIENTS (40 MALES; MEDIAN AGE, 66 YEARS) UNDERGOING TEVAR FOR THORACIC AORTIC ANEURYSM (34 TAA, 19 TAAA) OR PENETRATING AORTIC ULCER (N=4) BETWEEN 2001 AND 2010 WERE RETROSPECTIVELY REVIEWED. IN 28 PATIENTS, THE GORE TAG® STENT-GRAFT WAS USED, FOLLOWED BY THE MEDTRONIC VALIANT® IN 16 CASES, THE MEDTRONIC TALENT® IN 8, AND THE COOK ZENITH® IN 5 CASES. PROXIMAL LANDING ZONE (PLZ) WAS IN ZONE 1 IN 13, ZONE 2 IN 13, ZONE 3 IN 23, AND ZONE 4 IN 8 PATIENTS. IN 14 PATIENTS (25 %), THE PROCEDURE WAS URGENT OR EMERGENT. IN EACH CASE, PRE- AND POSTOPERATIVE CT ANGIOGRAPHY WAS ANALYZED USING A DEDICATED IMAGE PROCESSING WORKSTATION AND COMPLIMENTARY IN-HOUSE DEVELOPED SOFTWARE BASED ON A 3D CYLINDRICAL INTENSITY MODEL TO CALCULATE AORTIC ARCH ANGULATION AND CONICITY OF THE LANDING ZONES (LZ). RESULTS PRIMARY TYPE IA ENDOLEAK RATE WAS 12 % (7/57) AND SUBSEQUENT RE-INTERVENTION RATE WAS 86 % (6/7). LEFT SUBCLAVIAN ARTERY (LSA) COVERAGE (P=0.036) AND CONICITY OF THE PLZ (5.9 VS. 2.6 MM; P=0.016) WERE SIGNIFICANTLY ASSOCIATED WITH AN INCREASED TYPE IA ENDOLEAK RATE. BIRD-BEAK CONFIGURATION WAS OBSERVED IN 16 PATIENTS (28 %) AND WAS ASSOCIATED WITH A SMALLER RADIUS OF THE AORTIC ARCH CURVATURE (42 VS. 65 MM; P=0.049). TYPE IA ENDOLEAK WAS NOT ASSOCIATED WITH A BIRDBEAK CONFIGURATION (P=0.388). PRIMARY TYPE IB ENDOLEAK RATE WAS 7 % (4/57) AND SUBSEQUENT RE-INTERVENTION RATE WAS 100 %. CONICITY OF THE DISTAL LZ WAS ASSOCIATED WITH AN INCREASED TYPE IB ENDOLEAK RATE (8.3 VS. 2.6 MM; P=0.038). CONCLUSIONS CT-BASED 3D AORTIC MORPHOMETRY HELPS TO IDENTIFY RISK FACTORS OF TYPE I ENDOLEAK FORMATION AND BIRD-BEAK CONFIGURATION DURING TEVAR. THESE FACTORS WERE LSA COVERAGE AND CONICITY WITHIN THE LANDING ZONES FOR TYPE I ENDOLEAK FORMATION AND STEEP AORTIC ANGULATION FOR BIRD-BEAK CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186286 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention