BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 11775473 · Received May 5, 2021

    Report

    Report Number
    3001845648-2021-00369
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Report Date
    January 20, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 797 X UNKNOWN DOUBLE PIGTAIL BILIARY STENT DEVICE OF UNKNOWN RPN AND OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. PAPER REFERENCES A DOUBLE PIGTAIL PLASTIC STENT BEING UTILISED, ALTHOUGH THE DEVICE NAME IS NOT DOCUMENTED COOK¿S ZIMMON BILIARY STENTS OR SOLUS BILIARY STENTS ARE THE ONLY DOUBLE PIGTAIL STENTS AVAILABLE. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE, ¿TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE¿ DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL ¿SOLUS DOUBLE PIGTAIL STENT¿ DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THE SOLUS DOUBLE PIGTAIL STENT DEVICES COULD NOT BE COMPLETE AS THE LOT NUMBERS ARE UNKNOWN. AS PER INSTRUCTIONS FOR USE, IFU0100-1, INTENDED USE SECTION: ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ NOTES SECTION: ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ AS PER THE LITERATURE, THE BILIARY STENTS WERE USED FOR PANCREATIC DRAINAGE. SINCE THE EXACT NUMBER HAS NOT BEEN MENTIONED IN THE LITERATURE, A WORST-CASE SCENARIO APPROACH IS MADE AND 797 IS REPORTED AS THE QUANTITY OF BILIARY STENTS PLACED IN PANCREATIC DUCT. THE IFU CLEARLY STATES ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ THEREFORE, THE PLACEMENT OF DOUBLE PIGTAIL BILIARY STENT IN PANCREATIC DUCT IS CONSIDERED OFF LABEL. ROOT CAUSE REVIEW: A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. 2 CASES OF BLEEDING WERE REPORTED. HOWEVER, THE MEDICAL ADVISOR HAS CONFIRMED THAT ALTHOUGH THE BLEEDING IS IN RELATION TO THE STENT PLACEMENT PROCEDURE, IT CANNOT BE DIRECTLY ATTRIBUTED TO THE STENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. NO ADVERSE EVENTS WERE REPORTED IN THE LITERATURE THAT CAN BE ATTRIBUTED TO THE DEVICE COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS

    Description of Event or Problem · 0

    LEE ET AL (2018)- TRANSCATHETER ARTERIAL EMBOLIZATION FOR IATROGENIC BLEEDING AFTER ENDOSCOPIC ULTRASOUND-GUIDED PANCREATICOBILIARY DRAINAGE. TOTAL OF 797 EUS-TPBD PROCEDURES PERFORMING TRANSMURAL STENTING INTO THE BILE DUCT OR PANCREATIC DUCT WAS REVIEWED. ALL EUS-TPBD PROCEDURES WERE PERFORMED BY EXPERT GASTROINTESTINAL ENDOSCOPISTS. EUS-TPBD WAS CARRIED OUT USING A GF-UCT 240 LINEAR-ARRAY ECHOENDOSCOPE (OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) AND WAS PERFORMED BY DIRECTLY PUNCTURING THE DILATED INTRAHEPATIC BILIARY SYSTEM, PROXIMAL COMMON BILE DUCT OR PANCREATIC DUCT WITH A 19-GAUGE NEEDLE(EUSN-19-T; COOK ENDOSCOPY, WINSTON-SALEM, NC). THEN, THE TRACT WAS DILATED USING A 4 MM BALLOON DILATATION CATHETER, AND A 4F CANNULA (GLO-TIP, GT-1-UT; COOK) WAS ADVANCED OVER THE GUIDEWIRE. FINALLY, A PLASTIC STENT (DOUBLE PIG TAIL, COOK MEDICAL, WINSTON-SALEM, NC), A FULLY COVERED SELF-EXPANDABLE METAL STENT (MITECH, FC GROUP SEOUL, KOREA) OR A HYBRID STENT (BONA, STANDARD SCI TECH, SEOUL, KOREA) WAS THEN DEPLOYED OVER THE GUIDEWIRE. PAPER REFERENCES A DOUBLE PIGTAIL PLASTIC STENT BEING UTILISED, ALTHOUGH THE DEVICE NAME IS NOT DOCUMENTED COOK¿S ZIMMON BILIARY STENTS OR SOLUS BILIARY STENTS ARE THE ONLY DOUBLE PIGTAIL STENTS AVAILABLE. WHILE THE PAPER DOES NOT CONFIRM HOW MANY OF THE 797 DOUBLE PIGTAIL STENTS WERE PLACED IN THE PANCREATIC DUCT VERSUS BILIARY DUCT, WE WILL CONSERVATIVELY REPORT 797 AS THE QUANTITY FOR OFF-LABEL PLACEMENT IN PANCREATIC DUCT. THIS FILE WILL CAPTURE A POTENTIAL OF 797 CASES OF OFF-LABEL USE FOR BILIARY STENT BEING USED FOR PANCREATIC DRAINAGE.

    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
    672225 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female