BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 4218782 · Received October 30, 2014

    Report

    Report Number
    3001845648-2014-00212
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 25, 2014
    Report Date
    January 11, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002248905
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): P100022 AND S001. (B)(4). THIS EVENT IS CURRENTLY BEING INVESTIGATED AND THE INVESTIGATION CONCLUSION WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    (B)(4). ADVERSE EVENT REPORTED: WORSENED CLAUDICATION/RESET PAIN. PHYSICIAN INDICATED "POSSIBLY RELATED TO STUDY PRODUCT". (B)(6) 2014 (133 DAYS POST PROCEDURE) RE-INTERVENTION IN STUDY LESION (BALLOON/STENTING), PATIENT DISCHARGED SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696862 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G24890 C991947 10827002248905

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention