BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5225800 · Received November 16, 2015

    Report

    Report Number
    2031527-2015-00448
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 19, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE CLINICAL ASSESSMENT, THE REPORTED ENDOLEAK COULD NOT BE CONFIRMED, AND THE OUTCOME WAS, THEREFORE, INCONCLUSIVE. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. BASED UPON THE INVESTIGATION, THE ROOT CAUSE IS INCONCLUSIVE. NO DESIGN OR MANUFACTURING ISSUE WAS IDENTIFIED. THE CLINICAL REVIEW IDENTIFIED THE FOLLOWING FACTOR THAT MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME: ONE OF THE CUFFS WAS THE SAME SIZE DIAMETER AS THE MAIN BODY. ADDITIONAL DEVICE: MODEL BIFURCATED BA25-100/I16-40 LOT: W11-3742-002 REL. DATE: 11/30/2011 EXP. DATE: 7/31/2012.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL DEVICES: MODEL: A28-28/C95 V INFRARENAL AORTIC EXTENSION, LOT: 1164433-021, REL. DATE (B)(6) 2014, EXP. DATE: 4/21/2015. MODEL: I20-20/C55F-SA LIMB AORTIC EXTENSION, LOT: 1252560-021, REL. DATE: (B)(6) 2014. EXP. DATE: 06/25/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS. A SECONDARY WAS PERFORMED WHEN THE PHYSICIAN FOUND A TYPE 3A ENDOLEAK AND IMPLANTED TWO INFRARENALS AND A LIMB EXTENSION TO CORRECT. SUBSEQUENTLY, PATIENT NOW PRESENTED WITH AN UNKNOWN TYPE ENDOLEAK. PATIENT WILL BE BROUGHT IN FOR FURTHER EVALUATION AND POSSIBLE SECONDARY INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM THE REP 12/17/2015: EVEN THOUGH A TYPE 3B LEAK WAS NOT CONFIRMED OR DENIED, THE PHYSICIAN ELECTED TO RE-LINE THE PATIENT WITH A GORE DEVICE BACK IN MID (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS. A SECONDARY WAS PERFORMED WHEN THE PHYSICIAN FOUND A TYPE 3A ENDOLEAK AND IMPLANTED TWO INFRARENALS AND A LIMB EXTENSION TO CORRECT. SUBSEQUENTLY, PATIENT NOW PRESENTED WITH AN UNKNOWN TYPE ENDOLEAK. PATIENT WILL BE BROUGHT IN FOR FURTHER EVALUATION AND POSSIBLE SECONDARY INTERVENTION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755510 AFX INFRARENAL AORTIC EXTENSION MIH ENDOLOGIX, INC. A28-28/C95 V 1164431-026

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention