BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 7977048 · Received October 18, 2018

    Report

    Report Number
    9612515-2018-00021
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    July 17, 2018
    Report Date
    October 18, 2018
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115528
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE RETAINED MANUFACTURING AND QUALITY RECORDS (WITH SPECIFIC EMPHASIS OF THE BASE MATERIAL PERMEABILITY AND DEVICE POROSITY TESTING) CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO THE INTENDED SPECIFICATIONS. THE WHOLE BATCH OF 9 PASSED POROSITY TESTING WELL BELOW ACCEPTANCE LIMIT OF 77ML/MIN WITH MINIMUM READING OF 1ML/MIN AND HIGHEST READING OF 6ML/MIN. A REVIEW OF SIMILAR EVENTS WAS PERFORMED FOR ALL KNITTED DEVICES THAT HAVE BEEN REPORTED TO HAVE LEAKED. THE INCIDENT RATE FOR REPORTED LEAKAGE EVENTS WAS CONFIRMED AS (B)(4)% (COMPLAINTS V SALES). THE REVIEW INCLUDED ALL SIMILAR EVENTS REPORTED TO VASCUTEK BETWEEN JAN2013 - SEP 2018 INCLUSIVE. NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW. THE DISTRIBUTOR INFORMED VASCUTEK THAT THE DEVICE WOULD NOT BE MADE AVAILABLE AS IT REMAINS IN SITU WITHIN THE PATIENT'S ANATOMY, THEREFORE NO ANALYSIS OF THE DEVICE IS POSSIBLE. AS FURTHER DEVICE ANALYSIS IS NOT POSSIBLE, AND GRAFT MET ALL ACCEPTANCE CRITERIA DURING TESTING, VASCUTEK LTD CONSIDER THIS EVENT CLOSED.

    Description of Event or Problem · 1

    VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: THE PROSTHESIS AFTER BEING IMPLANTED IN THE PATIENT SHOWED A TEAR IN THE UNION OF BIFURCATION. DURING SURGERY THE GRAFT PRESENTS BLOOD LEAK WITH A SLIGHT NARROW AND UNUSUAL JET, THE SURGEON PROCEEDS TO SUTURE THE TEAR AND SOLVES THE EVENT, LEAVING THE PROSTHESIS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819174 GELSOFT PLUS GELSOFT PLUS DSY VASCUTEK LTD 16991563 0505 05037881115528

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention