BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 20841383 · Received December 4, 2024

    Report

    Report Number
    3001845648-2024-00739
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    May 30, 2017
    Report Date
    January 16, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510K#: K182980. DEVICE EVALUATION: THE ZIB6-40-10.0-60 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO A PMCF STUDY. MANUFACTURING RECORDS 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. INSTRUCTIONS FOR USE AND/LABEL REVIEW: AS PER THE INSTRUCTIONS FOR USE, IFU0040 WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR: ALLERGIC REACTION TO CONTRAST OR MEDICATION, ALLERGIC REACTION TO NITINOL, BILE DUCT ULCERATION, BILE LEAKAGE, BILOMA, CARDIAC ARRHYTHMIA OR ARREST, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION), FEVER, HEMOTHORAX, HEMATOMA, HEMORRHAGE, INFECTION/ABSCESS AT ACCESS SITE, INFLAMMATION, LIVER ABSCESS, NAUSEA/VOMITING, OBSTRUCTION OF THE PANCREATIC DUCT, PAIN/DISCOMFORT, PANCREATITIS, PERFORATION, PERITONITIS, PLEURAL EFFUSIONS, PLEURITIS, PNEUMONIA, PNEUMOTHORAX, RECURRENT OBSTRUCTIVE JAUNDICE, RESPIRATORY DEPRESSION OR ARREST, SEPSIS, STENT FRACTURE, STENT MIGRATION, STENT MISPLACEMENT, STENT OCCLUSION, TRAUMA TO THE BILIARY DUCT OR DUODENUM, TUMOR OVERGROWTH, TUMOR SEEDING, VASCULAR INJURY (INCLUDING PORTAL OR HEPATIC VEIN OR ARTERY). IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0040) LISTS ¿STENT OCCLUSION¿ AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS AND/OR A KNOWN POTENTIAL ADVERSE EVENT. THE CAUSE OF THIS OBSTRUCTION WAS UNDOCUMENTED AS PER PAGE 35 OF THE PMCF STUDY. HOWEVER AS PER PAGE 37 OF THE PMCF, THE EVENT WAS CONSIDERED TO BE NOT RELATED TO THE STUDY STENT OR PROCEDURE. ENDOSCOPIC TREATMENT INVOLVED THE PLACEMENT OF A NEW STENT. ALSO, AS PREVIOUSLY NOTED, ¿STENT OCCLUSION¿ IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL REPORTER, ON THE (B)(6) 2016 THE PATIENT UNDERWENT A STENTING PROCEDURE WHERE TWO ZIB6-40-10.0-60 DEVICES WERE IMPLANTED IN THE COMMON HEPATIC DUCT FOR BILE DUCT CANCER. THERE WERE NO ADVERSE EVENTS RELATED TO THE PROCEDURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED RECURRENT BILIARY OBSTRUCTION IN ONE OF THE PLACED STENTS. THE CAUSE OF THIS OBSTRUCTION WAS UNDOCUMENTED AS PER PAGE 35 OF THE PMCF STUDY. HOWEVER AS PER PAGE 37 OF THE PMCF, THE EVENT WAS CONSIDERED TO BE NOT RELATED TO THE STUDY STENT OR PROCEDURE. ENDOSCOPIC TREATMENT INVOLVED THE PLACEMENT OF A NEW STENT. ON (B)(6) 2018 THE PATIENT EXPERIENCED RECURRENT BILIARY OBSTRUCTION IN ONE OF THE PLACED STENTS FOR THE SECOND TIME. THERE WAS NO SIGN/SYMPTOMS AND THERE WAS NO TREATMENT. THIS IS CAPTURED IN (B)(4). THE CAUSE OF THIS OBSTRUCTION WAS UNDOCUMENTED AS PER PAGE 41 OF THE PMCF STUDY. HOWEVER AS PER PAGE 42 OF THE PMCF, THE EVENT WAS CONSIDERED TO BE NOT RELATED TO THE STUDY STENT OR PROCEDURE. CONFIRMED QUANTITY OF 01 X USED DEVICE. PATIENT DEATH WAS REPORTED ON THE (B)(6) 2019. AS PER PAGE 27 OF THE PMCF STUDY, THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO PRIMARY DISEASE PROGRESSION - BILE DUCT CANCER. AS PER MEDICAL ADVISOR INPUT, THE CAUSE OF DEATH WAS DUE TO PRIMARY DISEASE PROGRESSION.

    Description of Event or Problem · 0

    ON (B)(6) 2016, DATE OF FIRST IMPLANT PROCEDURE IN COMMON HEPATIC DUCT FOR BILE DUCT CANCER. X2 STUDY STENTS PLACED BOTH ZIB6-40-10-60. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. RE-CURRENT BILIARY OBSTRUCTIONS ON (B)(6) 2017. 190 DAYS POST PROCEDURE. OBSTRUCTION WITHIN STUDY STENT. PATIENT PRESENTED WITH NO SIGNS/SYMPTOMS. TREATMENT ENDOSCOPIC NEW STENT. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE, OR PROCEDURE. (B)(4). RE-CURRENT BILIARY OBSTRUCTIONS ON (B)(6) 2018. 430 DAYS POST PROCEDURE. OBSTRUCTION WITHIN STUDY STENT. NO SIGNS/SYMPTOMS AND NO TREATMENT. (B)(4). NEOPLASM PROGRESSION ON (B)(6) 2019. 1038 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. THE REINTERVENTIONS FOR RECURRENT BILIARY OBSTRUCTION WERE NOTED AS SUCCESSFUL. ON (B)(6) 2019, THE PATIENT DIED OF PRIMARY DISEASE PROGRESSION.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 16-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849957 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 74 YR Male Required Intervention