BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 9199413 · Received October 16, 2019

    Report

    Report Number
    3005580113-2019-00585
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    October 16, 2019
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING. D2B. PRODUCT CODE: NIU. EVENT HAS BEEN REPORTED BY THE MANUFACTURER UNDER MDR# 3001845648-2019-00542.

    Description of Event or Problem · 1

    THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD). THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN OCTOBER 2013 AND DECEMBER 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES, CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION, WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. IN THE UNMATCHED COHORT, THE ZILVER PTX PROCEDURES DID NOT SIGNIFICANTLY DIFFER IN TLR AND TVR RATES AT 1 YEAR FROM BMS PROCEDURES (TLR: 9.2% VS 13.8% [P=.10]; TVR: 9.8% VS 13.8% [P=.16]). IN THE PROPENSITY-SCORE MATCHED DATA, ZILVER PTX PROCEDURES HAD SIGNIFICANTLY LOWER TLR AND TVR RATES COMPARED TO BMS PROCEDURES (TLR: 9.2% VS 18.4% [P=.01]; TVR: 9.8% VS 18.4% [P=.02]). THIS COMPLAINT WAS CREATED TO CAPTURE THE TARGET VESSEL REVASCULARIZATION (TVR) RATES AT 1 YEAR FROM ZILVER PTX PROCEDURES WAS 9.8%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992957 UNKNOWN NIU UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R