BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 17049716 · Received June 2, 2023

    Report

    Report Number
    3001845648-2023-00436
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    October 26, 2022
    Report Date
    July 24, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S014. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S014. SUPPLEMENTAL REPORT IS BEING SUBMITTED AS REPORT IS BEING CANCELLED AS IT LONGER MEETS REPORTING REQUIREMENTS - CONFIRMATION ON 24-JUL-2023 FILE CAN BE CANCELLED SINCE IT IS UNCONFIRMED IF THE DEVICE WAS PLACED.

    Description of Event or Problem · 0

    PER MEDWATCH FORM: PATIENT UNDERWENT DIAGNOSTIC ARTERIOGRAM AND TRANSCATHETER INTERVENTION; FIRST STENT WAS DEPLOYED (PR 396544 LOT C1741457), AND MD REQUESTED AN ADDITIONAL STENT. PRIOR TO PLACEMENT, IT WAS DISCOVERED THE DATE ON THE STENT PACKAGING WAS EXPIRED (B)(6)2022. (PR (B)(6) LOT C1769805) DATE OF IMPLANT: (B)(6)2022. PATIENT OUTCOME: N/A - OCCURRENCE WAS DISCOVERED PRIOR TO PATIENT CONTACT. SG (B)(6)2023. PATIENT/EVENT INFO - NOTES: PLEASE PROVIDE THE ORIGINATOR A LIST OF ANY ADDITIONAL MANUFACTURER QUESTIONS REQUIRED FOR INVESTIGATION. SG (B)(6)2023 THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON (B)(6)2023. SG (B)(6)2023 IN THE SECTION ¿DESCRIBE EVENT¿ THE STATEMENT ¿FIRST STENT WAS DEPLOYED, AND MD REQUESTED AN ADDITIONAL STENT. PRIOR TO PLACEMENT, IT WAS DISCOVERED THE DATE ON THE STENT PACKAGING WAS EXPIRED (B)(6)2022.¿ WAS G38489 ¿ LOT C1741457 THE 1ST STENT PLACED? IF SO WAS IT REMOVED DUE TO THE EXPIRATION DATE, OR WAS IT JUST A STENT THAT YOU HAD ON HAND AND NOT USED? ALSO PLEASE CONFIRM THAT THE SECOND EXPIRED STENT WAS NOT USED ON THE PATIENT?

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS REPORT IS BEING CANCELLED AS IT LONGER MEETS REPORTING REQUIREMENTS - CONFIRMATION ON 24-JUL-2023 FILE CAN BE CANCELLED SINCE IT IS UNCONFIRMED IF THE DEVICE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898209 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G38488 C1769805 10827002384887

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male