BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 2926139 · Received January 17, 2013

    Report

    Report Number
    2954310-2012-81817
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 1, 1999
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADD'L INFO AND CLARIFICATION REGARDING THE CLINICAL OBSERVATIONS MENTIONED AND INVOLVEMENT OF THE ANCURE PRODUCT FROM THE ARTICLE AUTHOR(S) WERE UNSUCCESSFUL. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: M.T. VOUTE, F.M. BASTOS GONCALVES, J.M. HENDRIKS, R. METZ, M.R.H.M. VAN SAMBEEK, B.E. MUHS, H.J.M. VERHAGEN. "TREATMENT OF POST-IMPLANTATION ANEURYSM GROWTH BY LAPAROSCOPIC SAC FENESTRATION: LONG-TERM RESULTS" EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY; 2012: 44; 40-44.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFO VIA A REVIEW OF THE LITERATURE, A STUDY PERFORMED THAT DISCUSSED LONG TERM RESULTS OF TREATMENT OF POST-IMPLANTATION ANEURYSM GROWTH BY LAPAROSCOPIC SAC FENESTRATION. IN THIS STUDY, ONE PT WAS IDENTIFIED THAT WAS IMPLANTED WITH AN ANCURE ENDOGRAFT DEVICE 6.3 YEARS PRIOR. IT WAS NOTED THAT A TYPE II ENDOLEAK WAS OBSERVED WITH NO ANEURYSM GROWTH REPORTED. THE PT'S DISEASE AND PROGRESSED AND LED TO DILATATION OF A COMMON ILIAC ARTERY. THE LEAK WAS TREATED WITH AN ILIAC EXTENSION. NO ADVERSE PT EFFECTS WERE REPORTED AS A RESULT OF THE ADD'L PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25548 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| L| R