BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOVASCULAR

    MDR report key: 2801462 · Received October 11, 2012

    Report

    Report Number
    2017233-2012-00701
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    June 16, 2011
    Report Date
    September 16, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REGARDING SPECIFIC LOT/SERIAL NUMBERS AND PT INFO WAS REQUESTED BUT NOT AVAILABLE. THEREFORE, NO ANALYSES OR REVIEW OF THE MFG RECORDS COULD BE PERFORMED. THE ARTICLE DOES NOT SPECIFY OR INDICATE; AND GORE WAS UNABLE TO DETERMINE WHICH EVENT, IF ANY, EVENT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO. ADDITIONALLY, THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USA (IFU) SPECIFIES "PTS SHOULD BE COUNSELED AS TO THE POSSIBILITY OF SUBSEQUENT REINTERVENTIONS INCLUDING CATHETER-BASED AND OPEN SURGICAL CONVERSION." THE ARTICLE IDENTIFIED THE "MEAN" PT AGE AND SEX TO BE A (B)(6) MALE.

    Description of Event or Problem · 1

    AN ARTICLE PUBLISHED BY THE JOURNAL OF VASCULAR SURGERY, VOLUME 56, NUMBER 2 REVIEWED THE OUTCOMES OF ENDOVASCULAR REPAIR WITH SELECTIVE INTERNAL ILIAC ARTERY COVERAGE W/O COIL EMBOLIZATION. KONSTANTINOS O. PAPAZOGLOU, MD, PHD, A GEORGE S. SFYROERAS, MD, PHD, A STAVROS K. KAKKOS, MD, PHD, C AND MARIA MITKA, MD, A THESSALONIKI, ATHENS, AND PATRAS, GREECE. IN REVIEW OF THE PUBLISHED LITERATURE THE FOLLOWING FINDINGS WERE NOTED: BETWEEN (B)(6) 1997 AND (B)(6) 2010, 137 PTS UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF THEIR ABDOMINAL AORTIC ANEURYSM (AAA) WHICH INCLUDED INTENTIONAL COVERAGE OF THE INTERNAL ILIAC ARTERY (IIA). IN 112 PTS OF THE PTS THERE WAS NO EMBOLIZATION (NO EMBOLIZATION [NE] GROUP) OF THE IIA AND IN 25 PTS THE IIA WAS COIL EMBOLIZED (COIL EMBOLIZATION [CE] GROUP). COVERAGE OF THE IIA WAS BOTH UNILATERAL AND BI-LATERAL. ANATOMIC INDICATIONS FOR COVERAGE OF THE IIA W/O COIL EMBOLIZATION INCLUDED PRESENCE OF ADEQUATE SEALING IN THE DISTAL 5 MM OF THE CIA, OR SEALING RING AT THE ORIGIN OF THE CIA, OR IIA DIAMETER <5MM. PREOPERATIVE MEAN AAA SIZE WAS 60 - 14 MM, AND MEAN CIA DIAMETER WAS 38 - 13 MM. POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCANNING WAS PERFORMED AT 1, 6, AND 12 MONTHS, AND YEARLY THEREAFTER. (130 MEN; MEAN AGE, 70.9 YRS; RANGE, 45-92 YRS) THE PTS WERE FOLLOWED UP FOR 33 - 30 MONTHS. THE ARTICLE SPECIFIES THE FOLLOWING STENT GRAFTS WERE IMPLANTED IN THE 137 PTS INVOLVED IN THIS STUDY: EXCLUDER (N 57), TALENT (N 53), ENDURANT (N10), ANEURX (N 7), LIFEPATH (N 3), ENDOLOGIX (N 3), ENDOFIT (N 3), AND COOK ZENITH (N 1). THE ARTICLE DOES NOT SPECIFY WHICH DEVICE(S) ARE RELATED TO ANY INCIDENT REPORTED. THE RESULTS OF THE STUDY DEMONSTRATE THAT ENDOVASCULAR TREATMENT OF AORTOILIAC ANEURYSMS W/O COIL EMBOLIZATION OF THE IIA IS SAFE AND EFFECTIVE, IS ASSOCIATED WITH A LOW INCIDENCE OF POSTOPERATIVE COMPLICATIONS AND REINTERVENTIONS, AND HAS ACCEPTABLE MIDTERM RESULTS. THE ARTICLE REPORTS THE FOLLOWING SECONDARY ENDOVASCULAR INTERVENTIONS WERE PERFORMED: TWO REINTERVENTIONS TO REDO EVAR DUE TO PROXIMAL MIGRATION. FOUR REINTERVENTIONS FOR PLACEMENT OF A PROXIMAL CUFF. SIX REINTERVENTIONS TO PLACE CONTRALATERAL ILIAC EXTENDERS WITH CONCOMITANT CONTRALATERAL IIA OCCLUSION. ONE REINTERVENTION TO PLACE CONTRALATERAL ILIAC EXTENSION COILING OF THE ANEURYSM SAC. ONE REINTERVENTION FOR LIMB THROMBECTOMY. ONE REINTERVENTION TO PERFORM GRAFT LIMB STENTING. ONE REINTERVENTION TO PERFORM RENAL ANGIOPLASTY AND STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOVASCULAR MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention