BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPTFE MAXIFLO, SHORT TAPER WITH WRAP

    MDR report key: 3040020 · Received April 2, 2013

    Report

    Report Number
    9612515-2013-00001
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    December 2, 2013
    Report Date
    March 28, 2013
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K092863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT AVAILABLE FOR INSPECTION AND EVALUATION AS IT WAS NOT EXPLANTED. (THE DEVICE REMAINS IN SITU). RESULTS: AS NO PRODUCT IS CURRENTLY FOR INSPECTION AND EVALUATION, A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH THE AFFECTED PRODUCT (EPTFE MAXIFLO, SHORT TAPER WITH WRAP VASCULAR PROSTHESIS, LOT NO. P3574/9A, 4858, S/NO. (B)(4)) WAS UNDERTAKEN; THIS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS. CONCLUSIONS: NO CONCLUSIONS CAN BE DRAWN. AS NO PRODUCT HAS BEEN RETURNED FOR INSPECTION AND EVALUATION, THE ROOT CAUSE OF THE REPORTED PROBLEM COULD NOT BE ESTABLISHED AT THIS TIME. SEROMA FORMATION IS PTFE IN AN ULTRAFILTRATE OF SERUM. FAULTY INCORPORATION OF THE OUTER GRAFT WALL BY THE SURROUNDING TISSUES IS THE MAJOR CAUSE OF SERUM PASSAGE THROUGH THE GRAFT WALL. SEROMA FORMATION APPEARS TO BE AN ACCEPTED AND KNOWN PHENOMENON FOR PTFE PRODUCTS. (B)(4).

    Description of Event or Problem · 1

    VASCUTEK WAS NOTIFIED OF AN EVENT WHICH OCCURRED IN THE UNITED STATES OF AMERICA; THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: A VASCUTEK MANUFACTURED EPTFE MAXIFLO VASCULAR PROSTHESIS WAS IMPLANTED INTO A PATIENT ON (B)(6) 2012. ON (B)(6) 2013, THE DEVICE WAS EXPLANTED DUE TO THE FORMATION OF A SEROMA AROUND THE DEVICE. THE EXPLANTED VASCUTEK DEVICE WAS REPLACED WITH A GORE MANUFACTURED DEVICE. VASCUTEK WAS NOTIFIED THAT THE EXPLANTED VASCUTEK GRAFT WILL NOT BE RETURNED FOR INSPECTION AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135288 EPTFE MAXIFLO, SHORT TAPER WITH WRAP EPTFE MAXIFLO VASCULAR GRAFT DSY VASCUTEK LTD. EPTFE MAXIFLO P3547/9A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention