BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 16378784 · Received February 15, 2023

    Report

    Report Number
    3001845648-2023-00103
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    July 22, 2021
    Report Date
    March 11, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K182980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018 DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO PR 386828, PR (B)(4) (MDR - 3001845648-2023-00099) AND (B)(4) (MDR - 3001845648-2023-00100)AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. LAB EVALUATION ¿ N/A DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL ZIB DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) STATES THE FOLLOWING WARNING: ¿AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY OR IRRADIATION MAY INCREASE THE RISK OF A) STENT MIGRATION DUE TO TUMOUR SHRINKAGE, B) STENT EROSION OF THE TISSUE, AND/OR C) MUCOSAL BLEEDING.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USER NOT READING OF FOLLOWING THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED PATIENTS RECEIVED AT LEAST ONE CYCLE OF CHEMOTHERAPY POST STENT PLACEMENT, AS PER THE IFU WARNINGS ¿AFTER STENT PLACEMENT, ALTERNATIVE METHODS OF TREATMENT SUCH AS CHEMOTHERAPY OR IRRADIATION MAY INCREASE THE RISK OF A) STENT MIGRATION DUE TO TUMOUR SHRINKAGE, B) STENT EROSION OF THE TISSUE, AND/OR C) MUCOSAL BLEEDING.¿ SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER KUMAR ET AL ¿SURVIVAL BENEFIT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE FOR MALIGNANT BILIARY TRACT OBSTRUCTION ¿ A PROSPECTIVE STUDY COMPARING EXTERNAL AND INTERNAL DRAINAGE TECHNIQUES¿. ACCORDING TO THE INITIAL REPORTER, 35 PATIENTS RECEIVED AT LEAST ONE CYCLE OF CHEMOTHERAPY POST STENT PLACEMENT, THE CONFIRMED USED IS 10 DUE TO THE PLACEMENT OF 10 ZILVER STENTS IN THE STUDY, NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 11-MAR-2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.). 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

    KUMAR 2021 - SURVIVAL BENEFIT OF PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE FOR MALIGNANT BILIARY TRACT OBSTRUCTION¿A PROSPECTIVE STUDY COMPARING EXTERNAL AND INTERNAL DRAINAGE TECHNIQUES. STANDARD US AND FLUOROSCOPY GUIDED TECHNIQUES WERE USED TO INSERT SINGLE 8 FR EXTERNAL BILIARY DRAINAGE CATHETER (DEVON INNOVATIONS, BENGALURU, INDIA), 8.3 OR 10.2 FR INTERNAL-EXTERNAL RING BILIARY CATHETER (COOK, BLOOMINGTON, IN, USA) OR 10 MM DIAMETER ZILVER SELF-EXPANDING METALLIC STENT (COOK, BLOOMINGTON, IN, USA). BILIARY RADICLE PUNCTURE WAS DONE USING 18G PUNCTURE NEEDLE UNDER US GUIDANCE (LOGIQE, GE HEALTHCARE, USA) AND AFTER INSERTION OF A 5FR SHEATH (COOK, BLOOMINGTON, IN, USA) USING SELDINGER¿S TECHNIQUE, A 4FR MPA, C1 OR JR4 CATHETER (CORDIS, MIAMI, USA) WAS MANIPULATED ACROSS THE OBSTRUCTION OVER A 0.035 INCH NITINOL HYDROPHILIC GUIDEWIRE (TERUMO EUROPE) UNDER FLUOROSCOPIC GUIDANCE, AN AMPLATZ EXTRASTIFF GUIDEWIRE (COOK, BLOOMINGTON, IN, USA) WAS EXCHANGED AND AFTER SERIAL DILATATION WITH FASCIAL DILATORS (COOK, BLOOMINGTON, IN, USA), THE DEVICE WAS PLACED. ALL PATIENTS WERE OFFERED RING BILIARY CATHETER OR STENT PLACEMENT DURING THE CONSENT PROCESS; HOWEVER, IF CHOLANGITIS WAS PRESENT OR IN FAILURE TO CROSS THE OBSTRUCTION, AN EXTERNAL DRAINAGE CATHETER WAS INITIALLY PLACED AND SUBSEQUENTLY RING BILIARY CATHETER OR STENT WAS DEPLOYED. REPEAT INTERVENTIONS WERE DONE FOR DEVICE UPGRADATIONS OR DEVICE-RELATED ISSUES VIZ. BLOCKAGE, EXTENSIVE SOILING, BROKEN CATHETER HUB, ACCIDENTAL SLIPPAGE OR DISLODGEMENT OF THE CATHETER. 35 OUT OF THESE 48 CASES RECEIVED AT LEAST ONE CYCLE OF CHEMOTHERAPY (CT). THIS FILE WILL CONSERVATIVELY CAPTURE 10 CASES WHERE CHEMOTHERAPY WAS RECEIVED AFTER THE PLACEMENT OF THE ZILVER BILIARY STENTS. PATIENT/EVENT INFO - NOTES : MEAN AGE: 33 YEARS. GENDER: 7 MALE, 2 FEMALE.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 28-APR-2023.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2025 AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT (COMPLAINT DID NOT GO AGAINST THE STEPS OUTLINED IN THE IFU FOR THE SAFE & CORRECT USE OF THE DEVICE. ADVISING ''AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOUR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.). 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125953 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male