BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3962065 · Received July 28, 2014

    Report

    Report Number
    2031527-2014-00212
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    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

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT HAS BEEN CONFIRMED. A SAMPLE EVALUATION WAS NOT CONDUCTED AS THE DEVICE WAS NOT RETURNED. THERE MIGHT HAVE BEEN SUBSTANTIATING EVIDENCE OF: PROGRESSIVE STENT SEPARATION (STENT GRAFT COMPLAINT); ANEURYSMAL SAC INCREASE FROM TWO YEARS PRIOR (UNKNOWN ENDOLEAK); CONTAINED, AORTIC ANEURYSM RUPTURE; DEATH. THERE WAS SUBSTANTIATING EVIDENCE OF AN UNREPORTED SECONDARY PROCEDURE (COMPETITOR'S AORTIC STENT), AND A REPORTED (PATIENT ACCOUNT) BUT UNSUBSTANTIATED COMPLICATION OF AN ASSOCIATED ACUTE MYOCARDIAL INFARCTION FROM THAT REPAIR. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE MAY HAVE BEEN DUE TO STENT SEPARATION. HOWEVER, THERE WAS NO RADIOGRAPHICAL EVIDENCE OF AN ACTUAL ENDOLEAK, DUE TO THE NON-CONTRAST NATURE OF THE CT EXAMS, ONLY STENT SEPARATION. A MANUFACTURING RECORD REVIEW WAS PERFORMED; THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAVE BEEN CONSUMED AND OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING 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 REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS, THE PATIENT PRESENTED TO THE HOSPITAL SYMPTOMATIC ON (B)(6) 2014 SATURDAY WITH A RUPTURE. WHEN THE REP ARRIVED AT THE HOSPITAL THE CUFF WAS COMPLETELY SEPARATED FROM THE MAIN BODY. THE REP SAW A PREVIOUS SCAN WAS REVIEWED FROM 2012 AND THERE WAS A 2CM OVERLAP. PHYSICIAN WAS NOT ABLE TO DO THE CASE ON SATURDAY, DUE TO THE PATIENTS HEART ARREST AS SOON AS HE WAS INTUBATED. THEY HAD ADMINISTERED CHEST COMPRESSIONS WHICH RUPTURED HIS AAA EVEN FURTHER. PATIENT THEN EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438289 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-80LE W10-0141-021

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death