BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3900783 · Received June 27, 2014

    Report

    Report Number
    2031527-2014-00190
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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

    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 INVESTIGATION FINDINGS, THE REPORTED EVENT WAS CONFIRMED BASED ON CLINICAL ASSESSMENT OF MEDICAL RECORDS. THERE WAS ADEQUATE MEDICAL DOCUMENTATION AND SUBOPTIMAL IMAGING STUDIES AVAILABLE FOR REVIEW. THE RUPTURED STATE OF THE ANEURYSM AT INDEX INDICATED PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU. THE PATIENT'S HISTORY OF ANTIPLATELET THERAPY MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT. THE COMPLICATION OF A DISTAL EMBOLIC EVENT AND THE SECONDARY PROCEDURE TO TREAT THIS CONDITION WAS SUBSTANTIATED. THE PARTIAL OCCLUSION OF THE MAIN BODY AND CUFF WERE SUBSTANTIATED. THE INITIAL TYPE IIIA ENDOLEAK, RUPTURE, AND RETROPERITONEAL BLEED DURING THE FIRST EVENT PROCEDURE COULD NOT BE DEMONSTRATED RADIOGRAPHICALLY, BUT WAS ADEQUATELY SUBSTANTIATED IN THE MEDICAL DOCUMENTATION. THE UNKNOWN, PERSISTENT ENDOLEAK, THE SECONDARY OR PROCEDURE AND DEATH COULD NOT BE SUBSTANTIATED RADIOGRAPHICALLY, BUT WAS ADEQUATELY DESCRIBED IN THE MEDICAL DOCUMENTATION. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO 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. BASED ON THE INVESTIGATION FINDINGS, ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE EMERGENT NATURE OF THE INDEX PROCEDURE AND PATIENT CONDITION ARE LIKELY FACTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY A YEAR AGO AN EVENT (DATE UNKNOWN) OF POST IMPLANT OF A BIFURCATED DEVICE, AND AN AORTIC EXTENSION PATIENT PRESENTED TO THE ER SYMPTOMATIC WITH A RUPTURE AND WAS TREATED. REPORTEDLY, ON (B)(6) 2014 THE PATIENT PRESENTED WITH AN OVERLAP. A COMPUTED TOMOGRAPHY SCAN REVEALED A 3CM OVERLAP. THE PHYSICIAN ELECTED TO TREAT THE ENDOLEAK WITH AN AORTIC EXTENSION, AND AN ANGIO WAS DONE AFTER AND LOOKED GREAT. THE NEXT DAY THE ENDOLEAK PERSISTED, AND THE PHYSICIAN CHOSE TO RELINE WITH A COOK GRAFT. IT WAS REPORTED THAT THE PATIENT EXPIRED ONE DAY POST-SECONDARY PROCEDURE FROM UNSPECIFIED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378104 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other