BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 20937595 · Received December 16, 2024

    Report

    Report Number
    3001845648-2024-00823
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 25, 2018
    Report Date
    December 17, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K182980. SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS PER IFU 0040 WHICH ACCOMPANIES THESE DEVICES, INSTRUCTIONS RELATED TO ¿MULTIPLE STENT PLACEMENT¿ ARE PROVIDED WITHIN THE INSTRUCTIONS FOR USE, THEREFORE THERE IS NO USE ERROR. THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT WHEN CONFIRMATION WAS RECEIVED FROM THE QE ON 17DEC2024, AS PER IFU 0040 WHICH ACCOMPANIES THESE DEVICES, INSTRUCTIONS RELATED TO ¿MULTIPLE STENT PLACEMENT¿ ARE PROVIDED WITHIN THE INSTRUCTIONS FOR USE, THEREFORE THERE IS NO USE ERROR. THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 0

    ON (B)(6) 2018, DATE OF FIRST IMPLANT PROCEDURE NOT DOCUMENTED WHERE FOR PANCREATIC CANCER. STENT WAS DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. (B)(4). PRE AND POST STENT DILATION PERFORMED. PATIENT REQUIRED SURGERY FOR STRICTURE BEYOND STENT PLACEMENT/REPLACEMENT/ADJUSTMENT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. RE-CURRENT BILIARY OBSTRUCTIONS ON (B)(6) 2018. 65 DAYS POST PROCEDURE. OBSTRUCTION WITHIN STUDY STENT. PATIENT PRESENTED WITH NO SIGNS/SYMPTOMS. TREATMENT MEDICAL DRAINAGE. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE, OR PROCEDURE, RELATED TO CARCINOMA. (B)(4). NEOPLASM PROGRESSION ON (B)(6) 2018. 131 DAYS POST PROCEDURE. NO TREATMENT. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE, OR PROCEDURE, RELATED TO PROGRESSION OF CANCER. THE REINTERVENTION FOR RECURRENT BILIARY OBSTRUCTION WAS NOTED AS SUCCESSFUL. ON (B)(6) 2018, THE PATIENT DIED OF PRIMARY DISEASE PROGRESSION. THIS FILE WILL CAPTURE THE USE ERROR OF DEPLOYING A STENT THROUGH THE WALL OF A PREVIOUSLY DEPLOYED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328863 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female