BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER ENDOPROSTHESIS

    MDR report key: 3030624 · Received March 25, 2013

    Report

    Report Number
    2953161-2013-00044
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    August 8, 2012
    Report Date
    February 25, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ACCORDING TO THE INSTRUCTIONS FOR USE FOR THE GORE EXCLUDER AAA ENDOPROSTHESIS: KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION, SHORT PROXIMAL AORTIC NECK AND SIGNIFICANT THROMBUS AND / OR CALCIUM AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. DISTAL SEGMENT ILIAC VESSEL LENGTHS OF AT LEAST 30 MM OF WHICH AT LEAST 10 MM MUST BE LESS THAN OR EQUAL TO 18.5 MM IN DIAMETER FOR ILIAC EXTENDER ENDOPROSTHESIS: NON-ANEURYSMAL ILIAC ARTERY LENGTH EQUAL OR GREATER THAN 10 MM OF APPROPRIATE DIAMETER. ADDITIONALLY, THE IFU STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ENDOPROSTHESIS: ENDOLEAK, ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM 57MM IN DIAMETER AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS, FEATURING THE C3 DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE TYPE I ENDOLEAK. THE PATIENT WAS ADMINISTERED DALTEPARIN FOR COMORBIDITIES AND RECEIVED A HEPARIN INFUSION. ON (B)(6) 2012, THE PATIENT UNDERWENT REINTERVENTION FOR THE DISTAL TYPE I ENDOLEAK AND THE LEFT ILIAC LIMB WAS EXTENDED WITH AN ADDITIONAL GORE EXCLUDER CONTRALATERAL LIMB COMPONENT WHICH COMPLETELY RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT WAS REPORTED TO HAVE SIGNIFICANT CALCIUM IN THE DISTAL LANDING ZONE OF THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN ATTRIBUTES THE ENDOLEAK TO THE INCREASING SIZE OF THE PATIENT'S COMMON ILIAC ARTERY WHICH RANGED 23.5MM TO 6.5MM IN DIAMETER AT THE TIME OF THE INITIAL IMPLANT. THE DEVICE INVOLVED IN THIS EVENT HAD A ILIAC TREATMENT RANGE OF 10.0MM - 11.0MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122188 GORE EXCLUDER ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 8114894

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R AND RECEIVED A HEPARIN INFUSION.| DELATEPARIN FOR COMORBIDITIES| ENDOLEAK. THE PATIENT WAS ADMINISTERED| THE PATIENT WAS HOSPITALIZED FOR THE TYPE I