BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4187381 · Received October 21, 2014

    Report

    Report Number
    2017233-2014-00541
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    January 25, 2011
    Report Date
    January 22, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: OUTCOMES OF ABDOMINAL AORTIC ANEURYSM WITH AORTIC NECK THROMBUS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. J MED ASSOC THAI 2014; 97 (5): 518-24.(B)(6).

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: KHAMIN CHINSAKCHAI MD*,KIATTISAK HONGKU MD*, SUTEEKHANIT HAHTAPOMSAWAN MD*, CHUMPOL WONGWANIT MD*,CHANEAN RUANGSETAKIT MD*, NUTTAWUT SENNSATHANASAWADI MD, PHD*, PRAMOOK MUTIRANGURA MD* , VASCULAR SURGERY UNIT, DEPARTMENT OF SURGERY, FACULTY A/MEDICINE SIRIRAJ HOSPITAL, MAH IDOL UNIVERSITY, BANGKOK, THAILAND, ¿OUTCOMES OF ABDOMINAL AORTIC ANEURYSM WITH AORTIC NECK THROMBUS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR¿, J MED ASSOC THAI 2014; 97 (5): 518-24. TOTAL 145 PATIENTS UNDERGONE EVAR TREATMENT (N=21,MEAN AGE:76.1±7.0 YEARS; GENDER: 66.7% FOR MALE) BETWEEN JANUARY 2010 AND DECEMBER 2012 WERE INCLUDED TO INVESTIGATE THE INFLUENCE OF PROXIMAL AORTIC NECK THROMBUS MORPHOLOGY ON CLINICAL OUTCOMES AFTER EVAR. ONLY ONE PATIENT WAS IMPLANTED WITH GORE® ENDOPROSTHESIS . THE ARTICLE DESCRIBES THAT ONE PATIENT DEVELOPED THE GRAFT LIMB OCCLUSION ON THE SECOND POST-OPERATIVE DAY AFTER EVAR, WHICH PROBABLY RESULTED FROM NARROWING OF DISTAL AORTA, AND WAS SUCCESSFULLY TREATED BY GRAFT THROMBECTOMY AND KISSING BALLOON OF BOTH ILIAC LIMBS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE FACILITY WAS PROVIDED. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER ENDOPROSTHESIS (ITEM#: PXT231214 / LOT#: 8242306) FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. THERE REPORTEDLY HAS NO POSTOPERATIVE ENDOLEAK BEING DETECTED. IT WAS REPORTED THAT THE PATIENT DEVELOPED THE GRAFT LIMB OCCLUSION ON THE SECOND POST-OPERATIVE DAY, WHICH PROBABLY RESULTED FROM NARROWING OF DISTAL AORTA. THE GRAFT LIMB OCCLUSION WAS REPORTEDLY SUCCESSFULLY TREATED BY THE GRAFT THROMBECTOMY AND KISSING BALLOON OF BOTH ILIAC LIMBS. THE OPERATION WAS REPORTEDLY PERFORMED WITH: EVAR (A BIFURCATED GRAFT WAS ATTEMPTED BUT FAILED TO CANNULATE SHORT LIMB BECAUSE OF KINKED SHORT LIMB, THEN CONVERTED TO AUI TO THE LEFT SIDE USING PALMAZ STENT TO TOTALLY OCCLUDE SHORT LIMB OSTIA); PALMAZ STENT PLACEMENT AND FEMORO-FEMORAL CROSSOVER BYPASS. IT WAS REPORTED THE FINDINGS IN THE OPERATION INCLUDE: THE ANEURYSM HAD GOOD NECK BUT THERE WAS A RELATIVE STENOTIC PORTION BEFORE BECOMING ANEURYSM. THE SHORT LIMB OF THE MAIN BODY GRAFT WAS COLLAPSED AT THE LEVEL OF THE STENOTIC SITE MENTIONED ABOVE CAUSING FAILURE OF SHORT LIMB CANNULATION. THE CFAS HAD SOME ATHEROSCLEROTIC CHANGE WITH PLAQUES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE FACILITY WAS PROVIDED. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER ENDOPROSTHESIS (ITEM#: PXT231214 / LOT#: 8242306) FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. THERE REPORTEDLY HAS NO POSTOPERATIVE ENDOLEAK BEING DETECTED. IT WAS REPORTED THAT THE PATIENT DEVELOPED THE GRAFT LIMB OCCLUSION ON THE SECOND POST-OPERATIVE DAY, WHICH PROBABLY RESULTED FROM NARROWING OF DISTAL AORTA. THE GRAFT LIMB OCCLUSION WAS REPORTEDLY SUCCESSFULLY TREATED BY THE GRAFT THROMBECTOMY AND KISSING BALLOON OF BOTH ILIAC LIMBS. FINDINGS IN THE OPERATION INCLUDE: THE ANEURYSM HAD GOOD NECK BUT THERE WAS A RELATIVE STENOTIC PORTION BEFORE BECOMING ANEURYSM. THE SHORT LIMB OF THE MAIN BODY GRAFT WAS COLLAPSED AT THE LEVEL OF THE STENOTIC SITE MENTIONED ABOVE CAUSING FAILURE OF SHORT LIMB CANNULATION. THE CFAS HAD SOME ATHEROSCLEROTIC CHANGE WITH PLAQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667821 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8242306

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention