BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1915945 · Received December 6, 2010

    Report

    Report Number
    2031527-2010-00130
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    November 5, 2010
    Report Date
    May 10, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL # 28-16-120BL, LOT # W10-2971-025, EXPIRATION DATE 09/01/2013. DEVICE MANUFACTURE DATE 10/18/2010. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT SUFFERED SEPTIC SHOCK SECONDARY TO BOWEL NECROSIS FROM COMPLICATION DURING THE (B)(6) 2010 EVAR PROCEDURE. THE PATIENT SUBSEQUENTLY DIED ON AN UNKNOWN DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. (B)(4). PHYSICIAN INADVERTENTLY PERFORATED THE STENT GRANT WHILE REINTRODUCING GUIDEWIRE.

    Description of Event or Problem · 1

    AFTER SUCCESSFUL IMPLANT OF 28-16-100BL BIFURCATED DEVICE 0.014" GUIDEWIRE ACCESS WAS INADVERTENTLY LOST. SEVERAL ATTEMPTS TO REGAIN GUIDE WIRE ACCESS WERE ATTEMPTED; REINTRODUCTION WAS EVENTUALLY SUCCESSFUL. DURING REINTRODUCTION THE GUIDEWIRE PERFORATED THE LEFT LATERAL WALL OF THE STENT GRAFT, SMALL JETTING WAS NOTED DURING AN ANGIOGRAPHIC WORK UP. THE DECISION TO PLACE A SECOND BIFURCATED DEVICE OVER THE PERFORATED DEVICE WAS MADE. THE SECOND BIFURCATED DEVICE WAS SUCCESSFULLY IMPLANTED ALONG WITH AN AORTIC EXTENSION AND THREE LIMB EXTENSIONS, THE ENTIRE PROCEDURE TOOK APPROXIMATELY NINE HOURS TO COMPLETE. FOLLOW UP WITH PHYSICIAN REQUESTING PATIENT STATUS INDICATED THE PATIENT SHOWING SIGNS OF PARAPLEGIA; EXACT CAUSE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W10-2971-025

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| R