BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2960145 · Received February 13, 2013

    Report

    Report Number
    2031527-2013-00026
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, OPERATIVE NOTES FROM THE INDEX PROCEDURE AND SECONDARY PROCEDURE WERE REVIEWED BY A CLINICAL REPRESENTATIVE. BASED ON THE REVIEW OF MEDICAL RECORDS, IT INDICATES THAT THE PATIENT HAD DILATION OF HIS PROXIMAL AORTA AT THE LEVEL OF THE RENAL ARTERIES. THE PATIENTS ANATOMY (DILATED AORTA, NARROW AORTA AND ANGULATION) MAY HAVE CAUSED OR CONTRIBUTED TO THE PROXIMAL TYPE 1 ENDOLEAK. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND COMPLAINT HANDLING DATABASE, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    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. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 46 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. REPORTEDLY, THE PHYSICIAN IDENTIFIED A PROXIMAL TYPE I ENDOLEAK DURING A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN (APPROXIMATELY 30 MONTHS), WHICH WAS ORIGINALLY TREATED WITH A PALMAZ STENT GRAFT. HOWEVER, APPROXIMATELY 16 MONTHS LATER, A FOLLOW UP COMPUTED TOMOGRAPHY SCAN SHOWED THAT THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN ELECTED TO PLACE A SUPRARENAL AORTIC EXTENSION AND A COVER RENAL STENT; WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63903 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75L W08-3019-010

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention