BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM GRAFT

    MDR report key: 7051551 · Received November 21, 2017

    Report

    Report Number
    3011175548-2017-00304
    Event Type
    Injury
    Date Received
    November 21, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE INVESTIGATION WAS NOT ABLE TO BE PERFORMED AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. THE ARTICLE CONCLUDED SIGNIFICANTLY BETTER PATENCY RATES WERE ACHIEVED WITH THE HBD THAN WITH PTFE AT 3 YEARS, BUT THE DIFFERENCE WAS NO LONGER STATISTICALLY SIGNIFICANT AT 5 YEARS. THE INCIDENCE OF MAJOR LIMB AMPUTATION, HOWEVER, WAS SIGNIFICANTLY GREATER IN THE PTFE GROUP COMPARED WITH THE HBD GROUP AT BOTH 3 AND 5 YEARS OF FOLLOW UP.

    Description of Event or Problem · 1

    ARTICLE RECEIVED: DEVINE, C. A. (2004). HEPARIN-BONDED DACRON OR POLYTETRAFLUORETHYLENE FOR FEMOROPOPLITEAL BYPASS: FIVE-YEAR RESULTS OF A PROSPECTIVE RANDOMIZED MULTICENTER CLINICAL TRIAL. JOURNAL OF VASCULAR SURGERY, 40, 924-931. THE PURPOSE OF THIS IS TO COMPARE HEPARIN-BONDED DACRON (HBD) WITH POLYTETRAFLUOROETHYLNE (PTFE) IN A RANDOMIZED MULTICENTER CLINICAL TRIAL. PER THE ARTICLE: ADVERSE EVENTS IN THE PTFE GROUP INCLUDED: HEMATOMA, INFECTION, LYMPHEDEMA, CELLULITIS, HEMORRHAGE, PYREXIA, ANEMIA, CHEST INFECTION, OCCLUSIONS, STENOSIS AND AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829650 ATRIUM GRAFT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention