BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2960144 · Received February 13, 2013

    Report

    Report Number
    2031527-2013-00040
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, OPERATIVE NOTES FROM THE SECONDARY PROCEDURE AND CTA REPORTS WERE REVIEWED BY A CLINICAL REPRESENTATIVE. BASED ON REVIEW OF THE MEDICAL RECORDS A TYPE II ENDOLEAK EXISTED AT THE END OF THE SECONDARY PROCEDURE. BASED ON AVAILABLE INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, THE PATIENT ANATOMY (ILIAC ARTERY ANEURYSM) AND OR POSSIBLE INADEQUATE FIXATION OR SEALING OF THE STENT GRAFTS AT THE INDEX PROCEDURE MAY HAVE CONTRIBUTED TO THE EVENT. REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION, AND BILATERAL LIMB EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK ON THE RIGHT COMMON ILIAC ARTERY. IT COULD NOT BE DETERMINED IF THE ENDOLEAK WAS A TYPE II, OR TYPE III, BETWEEN THE LIMB EXTENSION AND THE BIFURCATED DEVICE. REPORTEDLY, A TYPE II WAS IDENTIFIED ON ANGIOGRAM DURING THE PROCEDURE; HOWEVER, THE PHYSICIAN ELECTED TO PLACE THE ADDITIONAL LIMB EXTENSION BETWEEN THE LIMB EXTENSION AND BIFURCATED DEVICE. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION, AND BILATERAL LIMB EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK ON THE RIGHT COMMON ILIAC ARTERY. IT COULD NOT BE DETERMINED IF THE ENDOLEAK WAS A TYPE II OR TYPE III BETWEEN THE LIMB EXTENSION AND THE BIFURCATED DEVICE. REPORTEDLY, THE PHYSICIAN ELECTED TO PLACE THE ADDITIONAL LIMB EXTENSION BETWEEN THE LIMB EXTENSION AND BIFURCATED DEVICE, WHICH DID NOT CORRECT THE ENDOLEAK. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND LEAVE THE ENDOLEAK FOR MONITORING. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62361 POWERLINK SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 20-13-88FL 1049089-009

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention