BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLUS BILIARY STENT AND INTRODUCER SET

    MDR report key: 11981573 · Received June 11, 2021

    Report

    Report Number
    3001845648-2021-00472
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 15, 2016
    Report Date
    January 21, 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: 10 X UNKNOWN SOLUS 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. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE, ¿A TWO-CENTER COMPARATIVE STUDY OF PLASTIC AND LUMEN-APPOSING LARGE DIAMETER SELF-EXPANDABLE METALLIC STENTS IN ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PANCREATIC FLUID COLLECTIONS¿ PR¿S CREATED FROM LITERATURE PAPER : (B)(6) (MDR REF: 3001845648-2021-00472) - ANG TL 2016 ¿ 10 CASES STENT MIGRATION - PS GROUP (SINGAPORE); (B)(6) (MDR REF: 3001845648-2021-00473)- ANG TL 2016 - 10 CASES RATE OF INADEQUATE DRAINAGE DESPITE CORRECT STENT (NO MIGRATION) - PS GROUP (SINGAPORE); PR (B)(6) (MDR REF: 3001845648-2021-00474) - ANG TL 2016 ¿ 5 ADVERSE EVENTS IN PS GROUP (SINGAPORE); (B)(6) - ANG TL 2016 ¿ 10 CASES STENT MIGRATION - PS GROUP (THAILAND); PR (B)(6) - ANG TL 2016 - 10 CASES RATE OF INADEQUATE DRAINAGE DESPITE CORRECT STENT (NO MIGRATION) - PS GROUP (THAILAND); (B)(6) - ANG TL 2016 ¿ 5 ADVERSE EVENTS IN PS GROUP (THAILAND). 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. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. 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.¿ ALSO, AS PER THE IFU POTENTIAL COMPLICATIONS SECTION: "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATIONS 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". STENT MIGRATION IS A KNOWN COMPLICATION ASSOCIATED WITH THE DEVICE. HOWEVER, IT IS CONFIRMED THAT DEVICE WAS USED OFF LABEL FOR TRANSMURAL DRAINAGE FOR PANCREATIC FLUID COLLECTIONS (PFCS) AND WALLED-OFF-NECROSIS(WON) EUS-GUIDED DRAINAGE OF PANCREATIC FLUID COLLECTIONS IS CONSIDERED OFF-LABEL USE 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. DUE TO THE OCCURRENCE, REPEAT ENDOSCOPIC DRAINAGE PROCEDURES WERE PERFORMED. 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

    ANG TL AT AL 2016 ¿ ¿A TWO-CENTRE COMPARATIVE STUDY OF PLASTIC AND LUMEN-APPOSING LARGE DIAMETER SELF-EXPANDABLE METALLIC STENTS IN ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PANCREATIC FLUID COLLECTIONS¿ AS PER TABLE 3 ¿ THIS FILE WILL CAPTURE 10 CASES STENT MIGRATION IN PS GROUP, 3 OF WHICH REQUIRED REPEAT STENTING. PLEASE NOTE, USE OF DOUBLE PIGTAIL SOLUS BILIARY STENT FOR PANCREATIC INDICATION IS CONSIDERED OFF LABEL USE. THIS PAPER TOOK PLACED IN THE (B)(6) AND (B)(6); THEREFORE, FILES HAVE BEEN CREATED TO COVER BOTH LOCATIONS. THIS FILE IS CAPTURING (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883703 SOLUS BILIARY STENT AND INTRODUCER SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention