BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE PIGTAIL BILIARY STENT

    MDR report key: 11981655 · Received June 11, 2021

    Report

    Report Number
    3001845648-2021-00488
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    October 8, 2019
    Report Date
    May 4, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: 1X UNKNOWN DOUBLE PIGTAIL BILIARY STENT DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR EVALUATION. THEREFORE, A DOCUMENT-BASED INVESTIGATION WILL BE CARRIED OUT. THIS FILE WAS OPENED FROM THE LITERATURE FILE, ¿LONG-TERM OUTCOME OF ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DUCT DRAINAGE USING A FULLY COVERED SELF-EXPANDABLE METAL STENT FOR PANCREATICOJEJUNAL ANASTOMOSIS STRICTURE.¿¿ LAB EVALUATION: N/A. IMAGE REVIEW: N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL DOUBLE PIGTAIL BILIARY STENT 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 THE ZIMMON BILIARY STENT DEVICE COULD NOT BE COMPLETE AS THE RPN AND LOT NUMBERS ARE UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045-7) STATES THE FOLLOWING: ¿INTENDED USE: ¿TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THIS COMPLAINT COVERS THE OFF-LABEL USAGE OF THE UNKNOWN DOUBLE PIGTAIL BILIARY STENT. PLACEMENT OF DOUBLE PIGTAIL BILIARY STENT FOR ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DUCT DRAINAGE (EUS-PD) IS CONSIDERED OFF-LABEL USE. THE PATIENT EXPERIENCED ABDOMINAL PAIN POST ENDOSCOPIC PROCEDURES. EUS-GUIDED PERIPANCREATIC FLUID COLLECTION DRAINAGE WAS PERFORMED 7 DAYS AFTER STENT PLACEMENT. 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. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALL COMPLICATIONS WERE IMPROVED BY CONSERVATIVE THERAPY OR ENDOSCOPIC PROCEDURES. 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

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

    Description of Event or Problem · 1

    DONGWOOK OH ET AL 2019 (DOUBLE PIGTAIL BILIARY STENT) ¿ ¿LONG-TERM OUTCOME OF ENDOSCOPIC ULTRASOUND-GUIDED PANCREATIC DUCT DRAINAGE USING A FULLY COVERED SELF-EXPANDABLE METAL STENT FOR PANCREATICOJEJUNAL ANASTOMOSIS STRICTURE¿. IN PATIENTS WITH PARTIAL PJA STRICTURES AND FAILED TRANSANASTOMOTIC AND TRANSMURAL PLASTIC STENTING, A TRANSANASTOMOTIC PLASTIC STENT (7F DOUBLE-PIGTAIL PLASTIC STENT 8¿12 CM IN LENGTH, COOK MEDICAL, WINSTON-SALEM, NC, USA) REVISION WITH 8-MM BALLOON DILATION WAS ATTEMPTED 2 MONTHS AFTER THE INITIAL TRANSMURAL METAL STENT PLACEMENT BECAUSE TRANSANASTOMOTIC AND TRANSMURAL PLASTIC STENTING WAS PRESUMED TO BE MORE PHYSIOLOGICALLY RELEVANT THAN TRANSMURAL METAL STENTING ALONE. OFF LABEL USE OF DOUBLE PIGTAIL PLASTIC STENT. PATIENT OUTCOME: PERIPANCREATIC FLUID COLLECTION (MODERATE GRADE, N = 1, THIS DEVELOPED AFTER DIRECT TRANSANASTOMOTIC AND TRANSMURAL PLASTIC STENT PLACEMENTS. EUS-GUIDED PERIPANCREATIC FLUID COLLECTION DRAINAGE WAS PERFORMED 7 DAYS AFTER STENT PLACEMENT). ABDOMINAL PAIN IMPROVED AFTER CONSERVATIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879404 DOUBLE PIGTAIL BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention