BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 6859409 · Received September 12, 2017

    Report

    Report Number
    2953161-2017-00176
    Event Type
    Injury
    Date Received
    September 12, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 20, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERVENTION PERFORMED ON (B)(6) 2016, WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 2953161-2017-00174 AND THE INTERVENTION PERFORMED ON (B)(6) 2017 WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 2953161-2017-00175, THEREFORE THIS REPORT WILL ONLY CAPTURE THE EXPLANT/OPEN SURGICAL REPAIR PERFORMED ON (B)(6) 2017. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC141400/06438613, PXC181000/06413442, PLA360400/14845911, PLA320400/12752120, PLA280300/13355441 AND PLA360400/15349369. UDI NUMBERS FOR THE LOTS ARE AS FOLLOWS: LOT 06440542: (B)(4), LOT 06438613: (B)(4), LOT 06413442: (B)(4), LOT 15349369: (B)(4), LOT 14845911: (B)(4), LOT 12752120: (B)(4), LOT 13355441: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. NO ADVERSE EVENTS WERE REPORTED. FINAL ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE PATIENT PRESENTED WITH BACK AND ABDOMINAL PAIN. FOLLOW-UP IMAGING WAS PERFORMED AND EVIDENCE OF A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. EVIDENCE OF DEVICE MIGRATION WAS NOT REPORTED AND IT IS REPORTEDLY UNKNOWN IF ANEURYSM ENLARGEMENT HAS OCCURRED. IT WAS REPORTED THE PROXIMAL TYPE I ENDOLEAK WAS CAUSED BY DISEASE PROGRESSION WHICH RESULTED IN NECK DILATION AND LOSS OF WALL APPOSITION BY THE TRUNK-IPSILATERAL LEG COMPONENT. LATER THAT SAME DAY, AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. THREE AORTIC EXTENDER COMPONENTS WERE IMPLANTED. REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, FOLLOW-UP IMAGING REPORTEDLY IDENTIFIED AN INCIDENTAL PROXIMAL TYPE I ENDOLEAK WITHOUT REPORTED COMMUNICATION WITH THE ANEURYSMAL SAC. EVIDENCE OF DEVICE MIGRATION WAS NOT REPORTED AND ONLY SLIGHT ANEURYSM ENLARGEMENT OF ~2-3 MM WAS NOTED. IT WAS REPORTED DISEASE PROGRESSION CAUSED THE AORTIC NECK TO DILATE AND THE AORTIC EXTENDER COMPONENT TO LOSE APPOSITION TO THE INFRARENAL NECK, RESULTING IN THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2017, AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. AN ADDITIONAL AORTIC EXTENDER COMPONENT AND A PALMAZ STENT WERE IMPLANTED FOR IMPROVED APPOSITION TO THE AORTIC WALL. REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE REPORT, ON (B)(6) 2017, THE PATIENT UNDERWENT EMERGENCY OPEN CONVENTIONAL CONVERSION REPAIR FOR FAILED ENDOVASCULAR REPAIR WITH RUPTURED AORTIC ANEURYSM. ACCORDING TO THE REPORT, THE AORTA WAS TRANSECTED JUST BELOW THE RENAL ARTERIES AND THE ANEURYSM SAC OPENED. ALL PREVIOUSLY IMPLANTED DEVICES WERE REMOVED OUT OF THE JUXTARENAL AORTA WITHOUT RESISTANCE. A 22 MM BIFURCATED HEMASHIELD DACRON PROSTHESIS WAS CUT TO AN APPROPRIATE LENGTH AND ANASTOMOSED END-TO-END TO THE AORTA AT THE JUXTARENAL LEVEL. PATIENT WAS TRANSPORTED TO THE CARDIO VASCULAR INTENSIVE CARE UNIT IN STABLE CONDITION. ACCORDING, TO THE PHYSICIAN, EVIDENCE OF A TYPE III ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN STATED THE CAUSE OF THE ENDOLEAK WAS DUE TO DEPLOYMENT OF ¿STACKED¿ AORTIC EXTENDER COMPONENTS WITHIN AN INAPPROPRIATE NECK FOR ENDOVASCULAR REPAIR. ACCORDING TO THE PHYSICIAN, THE INITIALLY IMPLANTED TRUNK WAS SIGNIFICANTLY OVERSIZED (PROXIMAL AORTIC NECK DIAMETERS NOT PROVIDED). THE EXPLANTED ENDOPROSTHESES WERE REPORTEDLY DISCARDED BY THE FACILITY AND THEREFORE ARE NOT AVAILABLE FOR EVALUATION BY GORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638984 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06440542

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R