BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2842896 · Received November 21, 2012

    Report

    Report Number
    2031527-2012-00165
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    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

    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

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION PERFORMED. HOWEVER, MEDICAL RECORDS WERE OBTAINED AND BASED ON DISCHARGE SUMMARY, OPERATIVE NOTES, PATIENT'S HISTORY AND PHYSICAL AND PRE-OPERATIVE ANESTHESIA NOTES REVIEWED BY CLINICAL REPRESENTATIVE, IT IS INDICATED THAT THE PATIENT (B)(6), HAD PREEXISTING HEALTH CONDITION OF HYPERTENSION AND COPD. A REVIEW OF THE PRE-OPERATIVE SIZING SHEET REVEALED THAT THE PATIENT HAD A SHORT PROXIMAL NON-ANEURYSMAL NECK OF 10 MM THAT WAS OUTSIDE THE DEVICES INDICATIONS. PER THE MEDICAL RECORDS, ENDOLEAK TYPE I EVENT HAS BEEN CONFIRMED. ENDOLEAK TYPE I WAS CORRECTED BY IMPLANTING ADDITIONAL SUPRARENAL AORTIC EXTENSION. A POTENTIAL ROOT CAUSE FOR THE ENDOLEAK TYPE 1 WAS THE PATIENT'S SHORT PROXIMAL NON-ANEURYSMAL NECK. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION; A COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK OF THE INFRARENAL AORTIC EXTENSION. REPORTEDLY, A JUXTARENAL ANEURYSM DEVELOPED AND MEASURED APPROXIMATELY 33 TO 33.5MM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A SUPRARENAL AORTIC EXTENSION AND TWO COMPETITOR'S STENTS, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-100LE W10-2374-015

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention