BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1491346 · Received October 2, 2009

    Report

    Report Number
    2031527-2009-00119
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    August 30, 2009
    Report Date
    June 11, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR PROXIMAL EXTENSION: MODEL NO. 25-25-75L LOT NO. W09-0856-014 EXPIRATION DATE: 04/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PATIENT PRESENTED WITH HYPERCOAGULABILITY AND CLOTTING ISSUES PRIOR TO THE INITIAL PROCEDURE; OPERATIVE NOTES WERE RECEIVED AND INDICATED A LARGE CLOT LOCATED WITHIN THE STENT GRAFT WHICH LED TO THE CONVERSION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FOR PROXIMAL EXTENSION: MODEL #: 25-25-75L. LOT#: W09-0856-014. EXP DATE: 04/01/2012. REVIEW OF THE LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PT HAD HYPERCOAGULABILITY/CLOTTING ISSUES PRIOR TO PROCEDURE. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    PT PRESENTED WITH HYPERCOAGULABILITY/CLOTTING ISSUES; HAD SUCCESSFUL IMPLANT OF A 25-16-140BL BIFURCATED DEVICE AND A 25-25-75L PROXIMAL EXTENSION IN 2009. F/U REVEALED THAT THE PT HAD NO FLOW TO THE LEGS. TWENTY FIVE DAYS LATER, THE PT WAS CONVERTED TO OPEN REPAIR AND THE DEVICES WERE EXPLANTED. THE PT TOLERATED THE PROCEDURE WELL. THE HOSP INADVERTENTLY DISCARDED THE EXPLANTED DEVICES.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH HYPERCOAGULABILITY/CLOTTING ISSUES; HAD SUCCESSFUL IMPLANT OF A 25-16-140BL BIFURCATED DEVICE AND A 25-25-75L PROXIMAL EXTENSION ON (B) (6) 2009. FOLLOW UP REVEALED THAT THE PATIENT HAD NO FLOW TO THE LEGS. ON (B) (6) 2009, THE PATIENT WAS CONVERTED TO OPEN REPAIR AND THE DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE HOSPITAL INADVERTENTLY DISCARDED THE EXPLANTED DEVICES. ADDITIONAL INFORMATION RECEIVED FROM OPERATIVE NOTES: PATIENT RETURNED TO OPERATING ROOM THE SAME DAY POST-IMPLANT WITH ACUTE ISCHEMIA OF THE LEFT LOWER EXTREMITY. LARGE CLOT WAS FOUND IN THE LEFT ILIAC/FEMORAL ARTERIES AND THE LEFT ILIAC STENT GRAFT LIMB WAS STENOTIC. THE STENOTIC PORTION OF STENT GRAFT WAS RE-STENTED WITH A VISI-PRO 8X57MM BALLOON EXPANDABLE BARE METAL STENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS PLACED ON ANTICOAGULATION. PATIENT RETURNED ON (B) (6) 2009; IT WAS NOTED THAT THE ENTIRE AORTIC STENT GRAFT WAS OCCLUDED WITH CLOT AND THUS, THE PATIENT WAS CONVERTED TO OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W09-1440-025

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention