BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 17161356 · Received June 20, 2023

    Report

    Report Number
    3001845648-2023-00474
    Event Type
    Injury
    Date Received
    June 20, 2023
    Report Date
    July 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA K#: P050017/S006. SUPPLEMENTARY REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE EVENTS REPORTED IN THIS REPORT ARE ALREADY CAPTURED IN (B)(4) (REPORT REFERENCE NUMBER: 3001845648-2023-00480).

    Additional Manufacturer Narrative · 0

    PMA K #P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTARY REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THE EVENTS REPORTED IN THIS REPORT ARE ALREADY CAPTURED IN (B)(4) (REPORT REFERENCE NUMBER: 3001845648-2023-00480).

    Description of Event or Problem · 0

    FRANSSON, 2023, RANDOMIZED CLINICAL TRIAL COMPARING DRUG ELUTING STENT ZILVER PTX® VERSUS BARE METAL STENT ZILVER FLEX® FOR TREATMENT OF LESIONS IN FEMORAL AND POPLITEAL ARTERIES IN CHRONIC LIMB THREATENING ISCHEMIA. PATIENTS PRESENTING WITH CLTI SCHEDULED FOR ENDOVASCULAR TREATMENT OF FP LESIONS WERE RANDOMLY ASSIGNED BY BLINDED ENVELOPES 1:1 IN A SINGLE BLINDED, PARALLEL GROUP DESIGN TO DES OR BMS AFTER LESION CROSSING. PRIMARY ENDPOINTS WERE TARGET LESION REVASCULARIZATION (TLR) AT 12 AND 24 MONTHS AND PRIMARY PATENCY AT 12 AND 24 MONTHS. SECONDARY ENDPOINTS WERE TECHNICAL SUCCESS (TS), CLINICAL SUCCESS, SECONDARY PATENCY AT 12 AND 24 MONTHS, LIMB SALVAGE, SERIOUS ADVERSE EVENTS (SAE) AT 24 MONTH AND SURVIVAL AT FIVE YEARS. THIS FILE WAS OPENED TO CAPTURE THE OCCURRENCE OF PREDISCHARGE RETREATMENT IN THE ZILVER FLEX GROUP. REQUIRE INTERVENTION/ADDITIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528001 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN
    783256 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention