BEUDAMED
    FDA Adverse Event Death Summary report: N

    COTTON-LEUNG BILIARY STENT SET

    MDR report key: 13441046 · Received February 3, 2022

    Report

    Report Number
    3001845648-2022-00058
    Event Type
    Death
    Date Received
    February 3, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 21, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002216706
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 1 X CLBS-10-12 DEVICE OF LOT C1821582 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION CLBS-10-12 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR CLBS-10-12 DEVICE OF LOT C1821582 WAS CONDUCTED AND IT WAS CONFIRMED THAT THIS FAILURE MODE HAD NOT PREVIOUSLY OCCURRED WITH THAT LOT. BASED ON THE INFORMATION TO DATE, THERE ARE NO MANUFACTURING ISSUES ASSOCIATED WITH LOT C1821582. AS PER INSTRUCTIONS FOR USE, IFU0045 WHICH ACCOMPANIES THIS DEVICE, POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, AS PER THE INSTRUCTIONS FOR USE, MIGRATION AND TRAUMA TO THE DUODENUM ARE KNOWN POTENTIAL COMPLICATIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED WITH THE COMPLAINT, "STENT MIGRATION AND A PERFORATION OF DUODENAL WALL 2-3 CM. A SURGERY WAS NECESSARY FOR SUTURING DUODENAL WALL. AFTER SURGERY PATIENT WAS SENT IN PALLIATIVE UNIT". ADDITIONAL INFORMATION RECEIVED ON 26-JAN-2022: 'I CONTACTED THE DR AND HE TOLD ME THAT STENT MIGRATION AND PERFORATION CONTRIBUTED TO DEATH OF PATIENT.' CLINICAL INPUT RECEIVED 27 JAN 2022: 1. WOULD THE PATIENTS PRE-EXISITING CONDITIONS HAVE AN IMPACT TO THE PATIENTS DEATH? "I WOULD BELIEVE SO. (B)(6) OLD PATIENT, IT DIDN¿T SPECIFY THE CANCER STAGE OR THE AGE OF THE PATIENT, WHICH WOULD HAVE A SIGNIFICANT IMPACT TO THE PATIENT. AFTER SURGERY, THE PATIENT WAS SENT IN PALLIATIVE UNIT, WHICH IMPLIED THIS PATIENT¿S GENERAL CONDITIONS". 2. IN YOUR CLINICAL OPINION, IS THERE A DIRECT OR INDIRECT LINK WITH THE COOK DEVICE AND DEATH? "I WOULD BELIEVE IT WAS INDIRECT LINK BETWEEN THE COOK DEVICE AND DEATH. THE DIRECT LINK MEANS THAT THE STENT MIGRATION CAUSED PATIENT¿S DEATH DIRECTLY WITHOUT OTHER PRE-EXISTING CONDITIONS; IN GENERAL, THIS PATIENT WOULD HAVE SURVIVED FROM A SURGERY SUTURING DUODENAL WALL. THE STENT MIGRATION WORSENED THE PATIENT¿S LATE STAGE CARCINOMA CONDITION, THEREFORE THE STENT MIGRATION WAS LINKED TO THE DEATH BUT DID NOT CAUSE PATIENT¿S DEATH DIRECTLY". COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE PATIENT HAD A TOMODENSITOMETRIQUE ABDOMINO-PELVIEN EXAM DONE. THE INDICATION OF THE EXAM WAS PANCREATIC AFTER CPRE. FOLLOWING THE RESULTS THE PATIENT WENT IN THE OPERATION THEATRE ON THE (B)(6). THE STENT WAS FOUND DOWN 3/4CM FROM HIS INITIAL POSITION. WHICH CREATED A 2/3 CM PERFORATION OF THE DUODENAL WALL OPPOSITE THE PAPILLA. "AS PER CC FORM": CUSTOMER INFORMATION : PATIENT HAD A TOMODENSITOMETRIQUE ABDOMINO-PELVIEN EXAM DONE. THE INDICATION OF THE EXAM WAS PANCREATIC AFTER CPRE. FOLLOWING THE RESULTS THE PATIENT WENT IN THE OPERATION THEATRE ON THE (B)(6). THE STENT WAS FOUND DOWN 3/4CM FROM HIS INITIAL POSITION. WHICH CREATED A 2/3 CM PERFORATION OF THE DUODENAL WALL OPPOSITE THE PAPILLA. DR TOLD ME THAT THEY PERFORMED AN ERCP FOR HILAR STENOSIS ON CHOLIANGIO CARCINOME OLD PATIENT. HE PERFORMED EXAMINATION WITHOUT PB AND HE DECIDED TO IMPLANT A PLASTIC STENT CLBS 10-12 AND A PANCRATIC STENT. IMPLANTATION WAS DONE WITHOUT PB ( PROBLEM ). DAY AFTER PATIENT DECLARED BELLY PAIN, THEY MADE A SCANNER AND BLOOD EXANIMATION. SCANNER SHOWED A PB AND THEY DECIDED TO DO ANOTHER ENDOSCOPY OF CONTROL. THIS ENDOSCOPY SHOWED A STENT MIGRATION AND A PERFORATION OF DUODENAL WALL 2-3 CM. A SURGERY WAS NECESSARY FOR SUTURING DUODENAL WALL. AFTER SURGERY PATIENT WAS SENT IN PALIATIVE UNIT. BEGINNING OF (B)(6) PAT. ADDITIONAL INFORMATION RECEIVED ON 26-JAN-2022: 'I CONTACTED THE DR AND HE TOLD ME THAT STENT MIGRATION AND PERFORATION CONTRIBUTED TO DEATH OF PATIENT.' CLINICAL INPUT RECEIVED ON (B)(6) 2022. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289516 COTTON-LEUNG BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1821582 10827002216706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D