BEUDAMED
    FDA Adverse Event Death Summary report: N

    BILIARY STENT

    MDR report key: 12414011 · Received September 2, 2021

    Report

    Report Number
    3001845648-2021-00631
    Event Type
    Death
    Date Received
    September 2, 2021
    Date of Event
    February 19, 2021
    Report Date
    October 21, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    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

    DEVICE EVALUATION: 4 X UNKNOWN BILIARY DEVICE OF UNKNOWN RPN OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE, ¿PREVALENCE OF AND RISK FACTORS FOR STENT MIGRATION-INDUCED DUODENAL PERFORATION. COMPLAINT FILES OPENED FROM THE JOURNAL ARTICLE STASSEN 2021: (B)(4) (MDR REF: 001845648-2021-00631) - STASSEN ET AL 2021 ¿STENT MIGRATION-INDUCED DUODENAL PERFORATION- DEATH¿. (B)(4) (MDR REF: 3001845648-2021-00632) - STASSEN ET AL 2021 ¿STENT MIGRATION-INDUCED DUODENAL PERFORATION'. DOCUMENT REVIEW: AS THE RPN AND THE LOT NUMBER OF THE DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL BILIARY STENT SET 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. THE INSTRUCTIONS FOR USE, IFU0045-7, IFU0100-1 WHICH ACCOMPANIES THESE DEVICES INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE AS PER INSTRUCTIONS FOR USE, IFU0045-7, IFU0100-1 WHICH ACCOMPANIES THESE DEVICES, 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 THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ALTHOUGH THE 4 DEATHS HAVE BEEN ATTRIBUTED TO THE THE STENT MIGRATION-INDUCED PERFORATION OF THE DUODENAL WALL (SMDP), THE MEDICAL ADVISOR HAS CONFIRMED THAT THE STENT CANNOT BE CONSIDERED AS THE DIRECT CAUSE TO THE PATIENT DEATH. THE JOURNAL MENTIONS THAT AMONG THE 4 PATIENTS DECEASED, ONLY 1 PATIENT UNDERWENT SURGERY. 2 WERE DIAGNOSED PROGRESSIVE METASTASIZED DISEASE AND WERE UNFIT FOR INVASIVE TREATMENT SHORTLY AFTER THE SMDP WAS DIAGNOSED. 1 PATIENT WAS DIAGNOSED WITH A MALIGNANT BENIGN HILAR STRUCTURE AND REFUSED FURTHER SURGICAL TREATMENT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE IS A DIFFICULT PATIENT ANATOMY. HOWEVER, AS PER THE INSTRUCTIONS FOR USE, MIGRATION IS A KNOWN POTENTIAL COMPLICATION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 4 PATIENTS AMONG THE 13 PATIENTS IN THE CLINICAL STUDY DECEASED DUE TO ABDOMINAL SEPSIS, HOWEVER MEDICAL ADVISOR HAS CONFIRMED IS NOT RELATED TO THE STENT AND IS LIKELY DUE THE THE PATIENT ANATOMY AND PRE- EXISTING CONDITIONS COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    STASSEN ET AL 2021 PREVALENCE OF AND RISK FACTORS FOR STENT MIGRATION-INDUCED DUODENAL PERFORATION. BETWEEN JANUARY 2014 AND DECEMBER 2017, IN 1227 PATIENTS (MEAN AGE 61 YEARS (SD ¿ 15.9 YEARS), 54% MALE) A TOTAL OF 2486 ERCS WERE PERFORMED. 13 PATIENTS WERE DIAGNOSED WITH AN SMDP (STENT MIGRATION-INDUCED PERFORATION OF THE DUODENAL WALL). ALL STENTS WERE STRAIGHT STENTS WITH A FLAP, FROM EITHER BOSTON SCIENTIFIC INC. OR COOK MEDICAL INC. 77% (10/13) WERE CLINICALLY SUSPECTED OF SMDP BASED ON THEIR PRESENTATION WITH ABDOMINAL PAIN, FEVER AND/OR INCREASED SERUM LEVELS OF INFLAMMATORY PARAMETERS. THE REMAINING 23% (3/13) WAS ASYMPTOMATIC AND SMDP WAS DIAGNOSED AT ELECTIVE STENT RETRIEVAL. IN 31% (4/13) THE PERFORATION WAS CONSIDERED TO BE A CONTAINED PERFORATION AND COULD THEREFORE BE TREATED CONSERVATIVELY WITH ONLY STENT REMOVAL. THESE PATIENTS DID NOT DEVELOP ANY COMPLICATIONS NOR NEEDED ADDITIONAL INTERVENTIONS. IN 62% (8/13) THE PERFORATION COULD BE CLOSED WITH AN OVER-THE-SCOPE CLIP (OTSC) AND 8% (1/13) HAD TO UNDERGO SURGERY SINCE THE PERFORATION WAS TOO LARGE TO BE SUCCESSFULLY TREATED BY ENDOSCOPIC MEANS. 38% (5/13) DEVELOPED INTRA-ABDOMINAL OR RETROPERITONEAL ABSCESSES FOR WHICH THEY UNDERWENT PERCUTANEOUS DRAINAGE. IN 8% (1/13) A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) DRAIN WAS PLACED. ENDOSCOPIC NASOBILIARY DRAINAGE WAS NOT ROUTINELY PERFORMED IN OUR PATIENTS. IN 15% (2/13) A RIGHT HEMICOLECTOMY NEEDED TO BE PERFORMED. IN THE FIRST PATIENT, THE STENT WAS PERFORATED THROUGH THE HORIZONTAL PART OF THE DUODENUM AND THE TIP OF THE STENT HAD CAUSED A FALSE ANEURYSM OF THE ILEOCOLIC ARTERY. THE ILEOCOLIC ARTERY HAD TO BE COILED WHICH LED TO AN ISCHEMIC CAECUM. IN THE SECOND PATIENT, A SUBMUCOSAL HEMATOMA IN THE WALL OF THE CAECUM TOGETHER WITH AN ISCHEMIC CAECUM WAS FOUND DURING SURGERY. THIS WAS PROBABLY CAUSED BY A FISTULA BETWEEN THE DUODENUM AND THE MESOCOLON OF THE COLON ASCENDENS, WHICH HAD DEVELOPED AFTER THE STENT PERFORATED THE DUODENAL WALL WITH EXTENSIVE RETROPERITONEAL INFILTRATION. 31% (4/13) DIED DUE TO ONGOING ABDOMINAL SEPSIS, DESPITE REPEATED ENDOSCOPIC, PERCUTANEOUS AND/OR SURGICAL INTERVENTIONS. TWO OF THESE PATIENTS WERE DIAGNOSED WITH AN IRRESECTABLE MALIGNANT HILAR STRICTURE AND WERE UNFIT FOR SURGERY, AND ONE ELDERLY PATIENT WITH A BENIGN HILAR STRICTURE REFUSED FURTHER SURGICAL TREATMENT AFTER FAILURE OF ENDOSCOPIC AND PERCUTANEOUS DRAINAGE, AND WISHED TO BE DISCHARGED WITH PALLIATIVE CARE AT HOME. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4 CASES OF PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313454 BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death