BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 20901120 · Received December 11, 2024

    Report

    Report Number
    3001845648-2024-00784
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    June 14, 2017
    Report Date
    December 17, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (CONFIRMATION RECEIVED FROM QE ON 17-DEC-24 THAT THIS COMPLAINT FILE CAN BE CANCELLED. 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.) FDA MDR REPORTING NOT REQUIRED: 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. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    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 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (CONFIRMATION RECEIVED FROM QE ON 17-DEC-24 THAT THIS COMPLAINT FILE CAN BE CANCELLED. 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.) FDA MDR REPORTING NOT REQUIRED: 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. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    ON (B)(6) 2015, THE PATIENT WAS TREATED FOR BILIARY OBSTRUCTION DUE TO PANCREATIC CANCER WITH PLACEMENT OF A ZIB6? -10.0-60 IN COMMON HEPATIC DUCT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. TRANSHEPATIC PRE-STENT DILATION PERFORMED. INTRA STENT POST DILATION PERFORMED. THE PATIENT EXPERIENCED RECURRENT BILIARY OBSTRUCTION WITHIN THE STUDY STENT. ON (B)(6) 2017, DUE TO TISSUE OR TUMOR INGROWTH. PATIENT PRESENTED WITH ABDOMINAL PAIN, NAUSEA AND VOMITING. INTERVENTION PERFORMED 664 DAYS POST PROCEDURE. TREATMENT ENDOSCOPIC INTERVENTION NEW STUDY STENT INSIDE STUDY STENT WITH ANTIBIOTICS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE OR PROCEDURE, RELATED TO PROGRESSION OF CANCER. BILIARY SEPSIS ON (B)(6) 2019. AT 1499 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. PATIENT DEATH ON (B)(6) 2019. DUE TO PRIMARY DISEASE PROGRESSION. THIS FILE WILL CAPTURE THE USE ERROR OF PLACING A STENT IN A PREVIOUSLY DEPLOYED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575355 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 77 YR Female