BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4192875 · Received October 22, 2014

    Report

    Report Number
    2017233-2014-00545
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 23, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.(B)(4). THE CAUSE OF THE DISTAL TYPE I ENDOLEAK IS REPORTEDLY UNKNOWN.

    Additional Manufacturer Narrative · 1

    PATIENT MEDICATIONS INCLUDE POTASSIUM CHLORIDE, JANUVIA, FLOMAX, TORSEMIDE, ASPIRIN, ATENOLOL, ATORVASTATIN, BISACODYL, DOCUSATE SODIUM, FERROUS SULFATE, GLIMEPIRIDE, LISINOPRIL, MAGNESIUM HYDROXIDE, PANTOPROAZOLE, AND POLYETHYLENE. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THE EVENT: PLC181200/12609693.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. AROUND (B)(6) 2014, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REPORTEDLY SHOWED EVIDENCE OF PROXIMAL AND DISTAL TYPE I ENDOLEAKS WITH NO EVIDENCE OF ANEURYSM ENLARGEMENT. THE EXACT CAUSES OF THE TYPE I ENDOLEAKS ARE REPORTEDLY UNKNOWN. HOWEVER, IT WAS REPORTED THERE WAS NON-CIRCUMFERENTIAL CALCIFICATION IN THE PROXIMAL NECK THAT MAY BE CONTRIBUTING TO THE PROXIMAL TYPE I ENDOLEAK, AND ONE SIDE OF THE TRUNK-IPSILATERAL LEG COMPONENT DID NOT APPEAR TO BE APPOSED TO THE PROXIMAL NECK. ON (B)(6) 2014, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE ENDOLEAKS. FOR THE DISTAL TYPE I ENDOLEAK, A CONTRALATERAL LEG COMPONENT WAS IMPLANTED FOR DISTAL EXTENSION. ANGIOGRAPHY SHOWED NO FURTHER EVIDENCE OF THE DISTAL LEAK. AN APTUS ENDOSYSTEM WAS USED IN AN ATTEMPT TO OBTAIN BETTER PROXIMAL WALL APPOSITION WITH ENDOSTAPLES. AFTER 20 ENDOSTAPLES WERE PLACED IN THE PROXIMAL NECK, ANGIOGRAPHY REPORTEDLY STILL SHOWED EVIDENCE OF THE PROXIMAL LEAK. AS IT WAS REPORTED THERE WAS NO ROOM FOR PROXIMAL EXTENSION DUE TO NEEDING TO PRESERVE AN ACCESSORY RENAL ARTERY IN THE PROXIMAL NECK, THE PROCEDURE WAS CONCLUDED WITH A POSSIBLE PLAN OF INTERVENING IN THE FUTURE. NO FURTHER ADVERSE EVENTS WERE REPORTED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673444 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10149235

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R