BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD PTFE FELT

    MDR report key: 1678191 · Received May 6, 2010

    Report

    Report Number
    2020394-2010-00161
    Event Type
    Death
    Date Received
    May 6, 2010
    Report Date
    April 8, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    PRE-AMENDMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED BY FDA THROUGH AN INQUIRY FOR ADDITIONAL INFO ON THE PRODUCT AND LOT NUMBER. THE USER FACILITY, PHYSICIAN, DETAILS OF THE PROCEDURE OR PT INFO WAS NOT DISCLOSED. THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVAL, SO TESTING COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED. THIS IS THE FIRST COMPLAINT RECEIVED FOR THIS LOT NUMBER TO DATE. NO NON-CONFORMANCE ISSUES RELATED TO THE MFG PROCEDURE STEPS AND/OR INSPECTIONS WERE FOUND THROUGH END PRODUCT DHR REVIEW. NO EVIDENCE WAS FOUND THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE STERILIZATION RECORDS, BIOBURDEN RECORDS AND LAL TESTING RECORDS WERE REVIEWED. ALL MET SPECIFICATIONS. THIS LOT WAS PROCESSED WITH ETHYLENE OXIDE IN A CYCLE THAT HAS BEEN VALIDATED TO ANSI-AAMI-ISO GUIDELINES FOR A STERILITY ASSURANCE LEVEL (SAL) OF (B) (4). ALL PRODUCTS IN THE LOT WERE CONSIDERED STERILE UNLESS THE PACKAGING INTEGRITY HAS BEEN COMPROMISED. THE PRODUCT IS LABELED AS "STERILE UNLESS THE PACKAGE IS OPENED OR DAMAGED". ALL BIOLOGICAL INDICATOR TESTING FOR THIS LOT WAS SUCCESSFULLY COMPLETED. BASED ON THE RECORDS REVIEWED, THE ROOT CAUSE FOR THE REPORTED FUNGAL INFECTION IS UNK. THIS FILE IS THE SAME PT AS MFR REPORT #2020394-2010-00163. TWO MDRS ARE BEING SUBMITTED AS TWO DIFFERENT LOT NUMBERS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 DAYS AFTER AN ABDOMINAL VASCULAR SURGICAL PROCEDURE, WHERE SEVERAL DEVICES HAD BEEN IMPLANTED, INCLUDING PTFE FELT, A VASCULAR GRAFT, ADHESIVE AND SEALANT, THE PT EXPIRED. REPORTEDLY, AN AUTOPSY REPORT REVEALED A FUNGAL INFECTION AND INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PTFE FELT PTFE FELT DXZ BARD PERIPHERAL VASCULAR, INC. HUTL0041

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death