BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4203227 · Received October 27, 2014

    Report

    Report Number
    2953200-2014-02197
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 4, 2013
    Report Date
    January 14, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE: SINGLE-CENTER EXPERIENCE IN THE ENDOVASCULAR MANAGEMENT OF ISOLATED ILIAC ARTERY ANEURYSM. MAN DEUK KIM, DO YUN LEE, MYUNGSU LEE, JONG YUN WON, SHIN JAE LEE, IL JUNG KIM, SUNG IL PARK, DONGHOON CHOI AND YOUNG-GUK KO. ACTA RADIOLOGICA 2014, VOL. 55(2) 195-200. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SURGICAL BYPASS CONVERSION, AIR BUBBLES, PAIN, RUPTURE, CLAUDICATION, PALPABLE MASS, LEG EDEMA, TYPE I ENDOLEAK. BACKGROUND: ISOLATED ILIAC ARTERY ANEURYSMS (IAA) ARE RELATIVELY UNCOMMON AND REPRESENT 2¿7% OF ALL INTRA-ABDOMINAL ANEURYSMS. SURGERY IS THE GOLD STANDARD TREATMENT FOR IAA. HOWEVER, ENDOVASCULAR STENT-GRAFT PLACEMENT IS GAINING ACCEPTANCE AS AN ALTERNATIVE TO SURGERY ESPECIALLY IN PATIENTS WITH HIGH SURGICAL RISK. PURPOSE: TO EVALUATE THE EFFECTIVENESS AND SAFETY OF ENDOVASCULAR MANAGEMENT OF ISOLATED IAA HAVING VARIOUS ANATOMIC AND PATHOLOGIC BASES. MATERIAL AND METHODS: BETWEEN 2008 AND 2011, 31 PATIENTS WHO UNDERWENT ENDOVASCULAR TREATMENT FOR ISOLATED IAA WERE RETROSPECTIVELY ANALYZED. THE MEAN ANEURYSM SIZE WAS 43MM (RANGE, 30¿71 MM). THE AGE RANGED FROM 37 TO 87 YEARS (MEAN, 70.0 YEARS). ISOLATED IAAS WERE TREATED IN ONE OF THREE DIFFERENT WAYS: (I) INFRARENAL AORTIC STENT-GRAFT PLACEMENT WITH LIMB EXTENSION; (II) STENT-GRAFT PLACEMENT FOR ISOLATED ILIAC ARTERY COVERAGE; AND (III) EMBOLIZATION WITH A COIL AND A VASCULAR PLUG COMBINED WITH FEMORAL-FEMORAL BYPASS GRAFTING. ALL PATIENTS WERE ASSESSED BY CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT). THE MEAN FOLLOW-UP PERIOD WAS 25.1 MONTHS (RANGE, 1¿60 MONTHS). RESULTS: COMMON ILIAC ARTERY INVOLVEMENT WAS SEEN IN 28 PATIENTS. TEN (35.7%) OF THOSE PATIENTS ALSO HAD AN INTERNAL IAA. THREE PATIENTS HAD AN ISOLATED INTERNAL IAA. INFRARENAL STENT-GRAFT PLACEMENT WAS PERFORMED IN 25 PATIENTS. STENTGRAFT PLACEMENT FOR COVERAGE OF THE ONLY ILIAC ARTERY WAS PERFORMED IN FIVE PATIENTS. ONE PATIENT, WHO HAD A MYCOTIC ANEURYSM OF THE RIGHT COMMON ILIAC ARTERY, UNDERWENT COIL EMBOLIZATION OF THE IPSILATERAL COMMON ILIAC ARTERY WITH CONCURRENT FEMORAL-FEMORAL BYPASS GRAFT. FIVE OF THE 31 PATIENTS (16.1%) WITH STENT GRAFTS HAD TYPE II ENDOLEAKS AT THE TIME OF THE LAST IMAGING STUDY, ONE OF THOSE PATIENTS UNDERWENT PERCUTANEOUS EMBOLIZATION WITH GLUE. NONE OF THE PATIENTS SHOWED MAJOR PROCEDURE-RELATED COMPLICATIONS. CONCLUSION: PERCUTANEOUS MANAGEMENT OF IAA IS EFFECTIVE AND SAFE WITH VARIOUS TECHNIQUES DEPENDING ON THE ANATOMICAL AND PATHOLOGIC FEATURES OF THE ISOLATED IAA.

    Description of Event or Problem · 1

    THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: FEVER, HEMATOMA, ANEURYSM ENLARGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683633 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention