BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 20842115 · Received December 4, 2024

    Report

    Report Number
    3001845648-2024-00747
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    December 6, 2019
    Report Date
    January 17, 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/510(K)#: K182980 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K182980. DEVICE EVALUATION THE ZIB6 DEVICE OF UNKNOWN RPN AND UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE ATTACHED PMCF STUDY AND WILL CAPTURE STUDY STENT OCCLUSION. 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. AS PER PAGE 30 AND PAGE 32 OF THE ATTACHED PMCF, THE CAUSE OF THE OBSTRUCTION WAS DUE TO TISSUE OR TUMOR INGROWTH WHICH WAS CAUSED BY THE PROGRESSION OF CANCER AND DEEMED NOT TO BE RELATED TO THE STUDY DEVICE OR PROCEDURE. 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)2019 THE PATIENT UNDERWENT A STENTING PROCEDURE WHERE TWO ZIB6 STENTS WERE PLACED IN THE COMMON BILE DUCT FOR BILE DUCT CANCER. THERE WERE NO ADVERSE EVENTS RELATED TO THE PROCEDURE. (B)(6)2019, THE PATIENT EXPERIENCED RE-CURRENT BILIARY OBSTRUCTION WITHIN ONE OF THE STUDY STENTS DUE TO TISSUE OR TUMOR INGROWTH WHICH WAS CAUSED BY THE PROGRESSION OF CANCER. TREATMENT INVOLVED AN ENDOSCOPIC INTERVENTION WITH TWO INTERNAL DRAINS. THE SITE DETERMINED THE EVENT TO NOT BE RELATED TO THE STUDY DEVICE, OR PROCEDURE AND RELATED TO THE PROGRESSION OF THE BILE DUCT CANCER. CONFIRMED QUANTITY OF (B)(4) USED DEVICE. PATIENT DEATH WAS REPORTED ON THE (B)(6)2019. THE CAUSE OF DEATH WAS UNKNOWN. AS PER MEDICAL ADVISOR INPUT, THE CAUSE OF DEATH WAS NOT RELATED TO THE COOK DEVICES AND WAS RELATED TO THE PROGRESSION OF CANCER.

    Description of Event or Problem · 0

    (B)(6) 2019 DATE OF FIRST IMPLANT PROCEDURE IN COMMON BILE DUCT FOR BILE DUCT CANCER. X2 ZIB6 STENTS PLACED ZIB6-?-10.0-40 AND A ZIB6-?-10.0-80 OF UNKNOWN LOT NUMBER AND 1X NON-STUDY STENT. NO ADVERSE EVENTS RELATED TO THE PROCEDURE. RE-CURRENT BILIARY OBSTRUCTIONS (B)(6) 2019. 7 DAYS POST PROCEDURE. OBSTRUCTION NOTED TO BE WITHIN A STUDY STENT. DUE TO TISSUE OR TUMOR INGROWTH. NOT DOCUMENTED IF PATIENT PRESENTED WITH SIGNS/SYMPTOMS. TREATMENT ENDOSCOPIC INTERVENTION 2 INTERNAL DRAINS. 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) 2019, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849991 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 81 YR Male Required Intervention