BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2202788 · Received August 11, 2011

    Report

    Report Number
    2031527-2011-00050
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. DEVICE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN IF THE PATIENT ANATOMY MET THE CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN. DEVICE WAS EVALUATED AND REASON FOR CAUSE UNKNOWN. THE DELIVERY SYSTEM AND EXPLANTED STENT GRAFT WERE RETURNED FOR EVALUATION. THERE WERE NO DAMAGES PRESENT ON THE STENT GRAFT OR THE DELIVERY SYSTEM THAT INDICATED THAT THERE WAS A MANUFACTURING ISSUE THAT CAUSED THE ISSUES EXPERIENCED IN THE REPORT. ALL THE ISSUES EXPERIENCED IN THE REPORT, SUCH AS THE WIRE WRAP AND THE DISPLACEMENT OF THE STENT GRAFT DURING RETRACTION ARE ALL CONSISTENT WITH ISSUES ENCOUNTERED IN TIGHT, TORTUOUS, AND/OR CALCIFIED ANATOMICAL CONDITIONS. THERE IS NO INDICATION THAT THE ISSUES EXPERIENCED IN THE REPORT WERE DUE TO A MANUFACTURING OR DESIGN ISSUE.

    Additional Manufacturer Narrative · 1

    READ MODEL # AS 22-16-100BL SHOULD READ 22-16-120BL, CORRECTION MADE.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER SHOULD READ: W11-2574-004.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE ADVANCING A BIFURCATED DEVICE THE PHYSICIAN EXPERIENCED DIFFICULTY. ONCE ADVANCED THE BIFURCATED DEVICE WAS UNSHEATHED AND SEATED ON THE AORTIC BIFURCATION. ONCE SEATED THE PHYSICIAN PULLED THE CONTROL CORD AND DEPLOYED THE MAIN BODY OF THE BIFURCATED DEVICE; HOWEVER THE SALES REPRESENTATIVE PRESENT AT THE PROCEDURE NOTED THE DEVICE DID NOT APPEAR TO BE FULLY DEPLOYED. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE INNER CORE OF THE DELIVERY SYSTEM; RESISTANCE WAS MET AND THE INNER CORE WOULD NOT RETRACT OUT OF THE IPSILATERAL LIMB. THE PHYSICIAN CONTINUED TO RETRACT THE INNER CORE WHICH PULLED THE BIFURCATED STENT GRAFT INTO THE IPSILATERAL COMMON ILIAC ARTERY; AT WHICH POINT THE PHYSICIAN ELECTED TO CONVERT TO OPEN REPAIR. THE PATIENT WAS REPORTED TO TOLERATE THE PROCEDURE WELL. THE EXPLANTED DEVICE AND DELIVERY SYSTEM WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 22-16-120BL W11-2574-004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention