BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1715740 · Received June 10, 2010

    Report

    Report Number
    2031527-2010-00069
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    May 6, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 34-34-80L LOT NO. W10-0088-004 EXPIRATION DATE: 2/16/2013; MODEL NO. 34-34-80L LOT NO. W10-0793-002 EXPIRATION DATE: 4/28/2013. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. DEVICE WAS RECEIVED AND EVALUATED BY ENDOLOGIX. DEVICE WAS RECEIVED WITH MULTIPLE KINKS IN THE INTRODUCER SHEATH INDICATIVE OF USE WITHIN A TORTUOUS PATIENT ANATOMY. THE KINKS WERE MANUALLY SMOOTHED OUT AND THE DEVICE WAS SUCCESSFULLY DEPLOYED. THE EVALUATION CONCLUDES THAT THERE IS NO INDICATION OF A MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION - MODEL: 34-34-80LE LOT: W10-0795-012/-013 EXPIRATION DATE: 04/12/2013. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PATIENT HAD NON-ANEURYSMAL BULGE LOCATED BELOW THE RIGHT RENAL MAKING IT DIFFICULT FOR THE STENT GRAFT TO SEAL.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH BILATERAL ANEURYSMAL ILIAC ARTERIES. PATIENT IMPLANT OF A 28-16-140BL BIFURCATED DEVICE, A 34MM PROXIMAL EXTENSION AND 16MM LIMB EXTENSIONS. AFTER IMPLANT OF THE 34MM PROXIMAL EXTENSION, AN INTRAOPERATIVE TYPE III ENDOLEAK WAS NOTED. A PALMAZ STENT WAS PLACED WHICH RESOLVED THE ENDOLEAK.

    Description of Event or Problem · 1

    PATIENT HAD NON-ANEURYSMAL BULGE LOCATED BELOW THE RIGHT RENAL. IMPLANT OF A 28-16-140BL BIFURCATED DEVICE AND TWO 34-34-80LE PROXIMAL EXTENSIONS. DUE TO THE BULGE AT THE RIGHT RENAL, THE PHYSICIAN HAD DIFFICULTY IN ACHEIVING SEAL. ANOTHER 34-34-80LE AND 34-34-100RLE PROXIMAL EXTENSIONS WERE IMPLANTED. THERE WAS AN INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK THAT COULD NOT BE RESOLVED WITH BALLOONING. THE PHYSICIAN DECIDED TO CONVERT THE PATIENT TO OPEN REPAIR. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W10-0749-004

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention