BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR-ENDURANT

    MDR report key: 4779463 · Received May 18, 2015

    Report

    Report Number
    9612164-2015-00703
    Event Type
    Injury
    Date Received
    May 18, 2015
    Date of Event
    February 17, 2015
    Report Date
    May 5, 2015
    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

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: TYPE II ENDOLEAK PREVENTION WITH COIL EMBOLIZATION DURING ENDOVASCULAR ANEURYSM REPAIR IN HIGH-RISK PATIENTS. DOMINIQUE FABRE, MD, ELIE FADEL, PHD, PHILIPPE BRENOT, MD, SARAH HAMDI, MD, ABEL GOMEZ CARO, MD, SACHA MUSSOT, MD, JEAN-PIERRE BECQUEMIN, MD, AND CLAUDE ANGEL, MD. (JOURNAL OF VASCULAR SURGERY (2015). HTTP://DX.DOI.ORG/10.1016/J.JVS.2015.02.030) BETWEEN JANUARY OF 2009 AND DECEMBER 2013 AN ENDURANT AND TALENT STENT GRAFT SYSTEM WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA WHICH REQUIRED A CUFF PLACEMENT, DISTAL STENT GRAFT KINKING, AND AN INADVERTENTLY COVERED LEFT RENAL ARTERY. OBJECTIVE: THIS STUDY EVALUATED ENDOLEAK LEVEL AND SIZE DECREASE OF INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH COIL EMBOLIZATION IN PATIENTS AT HIGH RISK FOR TYPE II ENDOLEAK. METHODS: BETWEEN 2009 AND 2013, 83 OF 187 PATIENTS (44.3%) WHO UNDERWENT EVAR FOR AAA ALSO UNDERWENT COIL EMBOLIZATION OF THE ANEURYSM SAC IMMEDIATELY AFTER COMPLETE STENT GRAFT RELEASE BECAUSE OF RISK FACTORS FOR TYPE II ENDOLEAK, INCLUDING ABSENCE OF A CIRCUMFERENTIAL THROMBUS, TWO OR MORE PAIRS OF PATENT LUMBAR ARTERIES, OR A PATENT INFERIOR MESENTERIC ARTERY. COIL EMBOLIZATION WAS ACHIEVED USING A 4F CATHETER WITH A MICROCATHETER PLACED BETWEEN THE STENT GRAFT AND THE ANEURYSM WALL. COMPUTED TOMOGRAPHY AND COLOR DUPLEX ULTRASOUND IMAGING WERE PERFORMED 1, 6, 12, AND 24 MONTHS LATER TO LOOK FOR AN ENDOLEAK AND ASSESS ANEURYSM SAC DIAMETER. RESULTS: MEAN FOLLOW-UP WAS 24 6 11 MONTHS (RANGE, 6-53 MONTHS). A MEAN OF 12 COILS (RANGE, 4-23) WAS USED. TECHNICAL SUCCESS WAS ACHIEVED IN ALL PATIENTS, WITH NO PROCEDURALLY RELATED COMPLICATIONS. FOLLOW-UP COMPUTED TOMOGRAPHY SHOWED TYPE II ENDOLEAK IN ONE PATIENT. ANEURYSM SAC DIAMETER WAS SIGNIFICANTLY DECREASED AFTER 6 MONTHS (P[ .001), 12 MONTHS (P [ .001), AND 24 MONTHS (P [ .001). SURGERY WAS REQUIRED IN ONE PATIENT FOR COMMON FEMORAL ARTERY OCCLUSION UNRELATED TO THE PROCEDURE AND IN ANOTHER PATIENT FOR DISTAL TYPE I ENDOLEAK. CONCLUSIONS: ANEURYSM SAC COIL EMBOLIZATION DURING EVAR FOR PATIENTS AT RISK FOR TYPE II ENDOLEAK IS TECHNICALLY FEASIBLE, SAFE, AND EFFECTIVE IN PREVENTING TYPE II ENDOLEAK. THIS PROCEDURE LEADS TO RAPID AAA SHRINKAGE. THUS, COIL EMBOLIZATION COULD BE USED ROUTINELY TO IMPROVE EVAR OUTCOMES FOR PATIENTS AT RISK FOR TYPE II ENDOLEAK. (J VASC SURG 2015;-:1-7.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321991 UNK-CV-SR-ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention