BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 12559997 · Received October 1, 2021

    Report

    Report Number
    3001845648-2021-00710
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    August 30, 2021
    Report Date
    October 6, 2021
    Product Code
    NIO
    UDI-DI
    10827002519050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CONFIRMATION RECEIVED ON (B)(6) 2021 THAT STENT FRACTURE WAS RELATED TO PREMATURE STENT DEPLOYMENT. CANCELLATION MDR BEING SUBMITTED FOR CURRENT (B)(4) (EMDR 3001845648-2021-00710) TO BE CANCELLED. (B)(4) (EMDR 3001845648-2021-00706) WILL CAPTURE BOTH. PMA/510(K) #: P050017/S006.

    Description of Event or Problem · 0

    CONFIRMATION RECEIVED ON (B)(6) 2021 THAT STENT FRACTURE WAS RELATED TO PREMATURE STENT DEPLOYMENT. CANCELLATION MDR BEING SUBMITTED FOR CURRENT PR (B)(4) (EMDR 3001845648-2021-00710) TO BE CANCELLED. (B)(4) (EMDR 3001845648-2021-00706) WILL CAPTURE BOTH.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: P050017/S006.

    Description of Event or Problem · 1

    DURING SURGERY, AFTER PRE-BALLOONING, IN THE SCLEROSIS PART, AFTER THE INSERTION OF THE DELIVERY SYSTEM OF THE STENT AND WIRE GUIDE, ALL OF THE STENT HAVE COME OUT EVEN BEFORE DEPLOYMENT AND UNLOCKING OF SAFETY LOCK. (DURING ADVANCEMENT) (SEPARATE COMPLAINT CAPTURING THIS ISSUE). STENT FRACTURE NOTED ON IMAGES PROVIDED. (THIS COMPLAINT IS TO CAPTURE STENT FRACTURE). PATIENT OUTCOME: DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? YES. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462570 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO C1626350 10827002519050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention