BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1893398 · Received November 3, 2010

    Report

    Report Number
    2017233-2010-00489
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 8, 2010
    Report Date
    November 2, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE(S) RELATED TO THE EVENT ARE: PCL161207/(B)(4). PCL161207/(B)(4). THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS, INSTRUCTIONS FOR USE STATES: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, ENDOLEAK, ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    ON (B)(6), 2004, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. ON (B)(6), 2010, THE PT UNDERWENT A REINTERVENTION FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND A CHRONIC TYPE II ENDOLEAK WITH SIGNS OF ENLARGEMENT. A RIGHT COMMON FEMORAL EXPOSURE, LEFT GROIN SEROMA DRAINAGE, RIGHT ILIAC COIL EMBOLIZATION AND EXTENSION OF THE STENT GRAFT WITH GORE EXCLUDER AAA ENDOPROSTHESIS WAS PERFORMED. IN ADDITION, THE PT UNDERWENT A RIGHT COMMON ENDARTERECTOMY AND ANGIOPLASTY WITH VEIN PATCH, AND PLACEMENT OF A WOUND V.A.C. TO THE LEFT GROIN. ON (B)(6), 2010, THE PT WAS RELEASED TO A SKILLED NURSING FACILITY. THE PHYSICIAN IS MONITORING THE PT. THE PT WAS SEEN ON (B)(6), 2010 AND IS DOING WELL, WITH SOME WOUND HEALING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 03022212

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| O| R MEGACE 400 P.O. DAILY| POTASSIUM CHLORIDE 20 MEQ P.O. B.I.D.| CAPTOPRIL 50MG P.O. Q.8H| POTASSIUM CHLORIDE| TYLENOL| COLCHICINE 0.6 P.O. AT BEDTIME| ZOCOR| SENNA| DISCHARGE MEDICATIONS: VITAMIN B12 1000 P.O. DAILY| MEDICATIONS ON ADMISSION: VITAMIN B12| LASIX 40 P.O. B.I.D.| SENNA 2 TABS P.O. DAILY| CALCITONIN 200 DAILY| MULTIVITAMIN P.O. DAILY| SYNTHROID 75MCG P.O. DAILY| PRILOSEC 40 MG P.O. DAILY| ZOCOR 40 MG P.O. AT BEDTIME| TYLENOL 650 P.O. Q.4 H. P.R.N. FOR PAIN/FEVER| TUMS 1000 P.O. DAILY| ZINC 220 P.O. DAILY| VITAMIN C 500 P.O. B.I.D.| MIRALAX| SYNTHROID| COUMADIN 1 MG P.O. DAILY| COLACE 100 P.O. B.I.D.| LYRICA 25 P.O. Q.12H.| NORVASC 5 P.O. DAILY| LASIX 20 P.O. EVERY OTHER DAY| THIAMINE 160 DAILY| COLCHICINE 0.6 P.O. AT BEDTIME| ASPIRIN 81 DAILY| VICODIN| COUMADIN| LOPRESSOR| COLACE| PRILOSEC| NORVASC| XANAX