BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3093931 · Received April 25, 2013

    Report

    Report Number
    2953161-2013-00057
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    September 7, 2012
    Report Date
    March 15, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION - THE EXACT CAUSE OF THE ENDOLEAK IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK ASSOCIATED WITH THE AORTIC EXTENDER COMPONENT WITH 1 CM ANEURYSM ENLARGEMENT. IT WAS REPORTED THE EXACT CAUSE OF THE ENDOLEAK IS UNKNOWN, AND NO MIGRATION HAS BEEN IDENTIFIED. ON (B)(6), 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE ENDOLEAK. AN ADDITIONAL AORTIC EXTENDER COMPONENT WAS IMPLANTED FOR PROXIMAL EXTENSION. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178851 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 9503795

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R AMLODIPINE| POTASSIUM CHLORIDE| BENADRYL| ALBUTEROL| FERROUS SULFATE| PERCOCET| ARICEPT| BESYLATE| OMEPRAZOLE| CALCIUM CARBONATE ANTACID| ASPIRIN| NAMENDA| LASIX| BACLOFEN| LEVOTHYROXINE| ONDANSETRON| OMEGA 3 KRILL OIL| LISINOPRIL| LIPITOR