BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2873204 · Received December 13, 2012

    Report

    Report Number
    2031527-2012-00178
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED, HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, CT PRE-OPERATIVE IMAGES, ANGIOGRAM AND DEATH CERTIFICATE WERE RECEIVED AND REVIEWED BY THE MEDICAL DIRECTOR. BASED ON THE REVIEW OF THE IMAGES AND CERTIFICATE, THE PATIENT PRESENTED WITH A VERY LARGE ANEURYSM, COMPLICATED BY ILIAC ANEURYSMS. DURING THE INTERVENTION TO TREAT THE REPORTED TYPE I ENDOLEAK, COMPLICATIONS WITH SIGNIFICANT BLOOD LOSS AND EXTENSIVE PATHOLOGY RESULTED IN THE PATIENT'S DEATH. THE ETIOLOGY OF THE TYPE I ENDOLEAK COULD NOT BE DETERMINED. THE MANUFACTURING RECORD REVIEW DID NOT REVEAL ANY ISSUES OR DEVIATION THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT MET ALL REQUIREMENTS PRIOR TO RELEASE, WITH NO NONCONFORMING MATERIAL RECORDS ASSOCIATED TO THE INVOLVED LOT. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND PREVIOUS COMPLAINTS, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING, UNDER POTENTIAL ADVERSE EVENTS. ADDITIONALLY, THE DEVICE INSTRUCTIONS FOR USE UNDER WARNINGS AND PRECAUTIONS INCLUDE: PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT SUCH AS DUE TO NEGATIVE REMODELING OF THE ANEURYSM OR DISEASE PROGRESSION) SHOULD RECEIVE ENHANCED FOLLOW-UP.

    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.

    Description of Event or Problem · 1

    THE PATIENT DIED ON (B)(6) 2012 AND THE DEATH CERTIFICATE INCLUDED AS CAUSE(S) OF DEATH: CARDIOGENIC SHOCK AND ACUTE RENAL FAILURE; HEMORRHAGIC SHOCK SECONDARY TO MASSIVE INTRAOPERATIVE BLOOD LOSS; RUPTURED RIGHT ILIAC ARTERY ANEURYSM; ABDOMINAL AORTIC BILATERAL ILIAC ARTERY ANEURYSM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANT OF A SUPRARENAL AORTIC EXTENSION, A BIFURCATED DEVICE, AND TWO LIMB EXTENSIONS, DURING SURGICAL TREATMENT OF A PREVIOUSLY DETECTED ENDOLEAK ON THE LEFT SIDE [REFERENCE MANUFACTURER REPORT NUMBER 2031527-2012-00175], A SLIGHT DISTAL TYPE I ENDOLEAK WAS NOTED ON THE RIGHT SIDE. THE PATIENT WAS SCHEDULED FOR SURGICAL REPAIR OF THE RIGHT DISTAL TYPE I ENDOLEAK APPROXIMATELY 21 DAYS LATER. DURING THE REPAIR OF THE RIGHT DISTAL TYPE I ENDOLEAK, THE PATIENT BLOOD PRESSURE BEGAN TO DROP. DIAGNOSTIC IMAGING REVEALED A RUPTURE IN THE ILIAC ARTERY DISTAL TO IMPLANTED STENT GRAFT. THE PHYSICIAN CUT DOWN TO EXPOSE AND REPAIR THE RUPTURED VESSEL. THE PHYSICIAN PERFORMED AN AXILLO-FEMORAL BYPASS TO RESTORE DISTAL BLOOD FLOW. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO INTENSIVE CARE, WHERE REPORTEDLY APPROXIMATELY 24 TO 36 HOURS POST-OPERATIVE THE PATIENT PASSED AWAY DUE TO MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 20-13-88FL W11-1160-014

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R