BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 10618560 · Received October 2, 2020

    Report

    Report Number
    3001845648-2020-00741
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    November 20, 2004
    Report Date
    November 15, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE GEENEN PANCREATIC STENT OF UNKNOWN LOT NUMBER AND RPN 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. COMPLAINTS (B)(4) WERE OPENED FROM THIS PAPER. (B)(4) (3001845648-2020-00740) WAS OPENED TO CAPTURE STENT OCCLUSION IN 5 PATIENTS INVOLVING THE GEENEN PANCREATIC STENT (RPN: UNKNOWN). THIS COMPLAINT WAS OPENED TO CAPTURE OFF-LABEL USE IN 92 PATIENTS INVOLVING THE GEENEN PANCREATIC STENT (RPN: UNKNOWN). DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL GEENEN PANCREATIC 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. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0055-4) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ WHERE THE PROPHYLACTIC USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. IN THIS STUDY 97 PATIENTS WITH PD (PANCREATIC DUCT) DISRUPTION WERE IDENTIFIED AND UNDERWENT TRANPAPILLARY PD STENT INSERTION WITH A SUCCESS RATE OF 95% (92/97). A 0.035-INCH WIREGUIDE WAS INSERTED INTO THE PD AND A GEENEN PANCREATIC STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) WITH AN INTERNAL FLAP WAS INSERTED. WHEN A 3FR STENT WAS INSERTED, A SMALL CUT WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP. THE PD WAS CANNULATED WITH AN 0.018-INCH GUIDEWIRE WHEN THERE WAS AN EXTREMELY NARROW PD STRICTURE OR WHEN A 3FR STENT WAS PLACED. PANCREATOGRAPHY WAS OBTAINED IN ALL PATIENTS AT STENT REMOVAL, WHICH USUALLY WAS DONE 6 TO 8 WEEKS AFTER PLACEMENT. FOR A PERSISTENT LEAK, A NEW STENT WAS PLACED AND WAS EXCHANGED AT INTERVALS OF 6 TO 8 WEEKS. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE IN THIS CASE PROPHYLACTIC USE OF THE DEVICE. IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. 92 PATIENTS HAD GEENEN PANCREATIC STENTS INSERTED TO TREAT FISTULA AND THE 3FR STENT WAS ALTERED WHEN AN INCISION WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP, THIS IS REGARDED AS OFF-LABEL USE. ACCORDING TO CLINICAL INPUT RECEIVED THE ONE PATIENT WHO DIED AFTER MULTIORGAN FAILURE FOLLOWING PD STENT INSERTION WAS CAUSED OR CONTRIBUTED TO BY THE GEENEN PANCREATIC STENT. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED THERE WERE NO ADVERSE EFFECTS TO THE PATIENTS AS A RESULT OF THE OFF-LABEL USE. 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

    "VARADARAJULU ET AL 2005 (GEENEN PS), 'PREDICTORS OF OUTCOME IN PANCREATIC DUCT DISRUPTION MANAGED BY ENDOSCOPIC TRANSPAPILLARY STENT PLACEMENT'. ERCP WAS PERFORMED WITH THE PATIENT UNDER STANDARD CONSCIOUS SEDATION. UPON IDENTIFICATION OF THE PD DISRUPTION AS EXTRAVASATION OF CONTRAST INTO THE PFC, A 0.035-INCH GUIDEWIRE WAS INSERTED INTO THE PD AND A GEENEN PANCREATIC STENT (WILSON-COOK MEDICAL INC, WINSTON-SALEM, NC) WITH AN INTERNAL FLAP WAS INSERTED. WHEN A 3F STENT WAS PLACED, A SMALL CUT WAS MADE ON THE STENT TO CREATE AN INTERNAL FLAP. THE PD WAS CANNULATED WITH A 0.018-INCH GUIDEWIRE WHEN THERE WAS AN EXTREMELY NARROW PD STRICTURE OR WHEN A 3F STENT WAS PLACED. PANCREATOGRAPHY WAS OBTAINED IN ALL PATIENTS AT STENT REMOVAL, WHICH USUALLY WAS DONE 6 TO 8 WEEKS AFTER PLACEMENT. FOR A PERSISTENT LEAK, A NEW STENT WAS PLACED AND WAS EXCHANGED AT INTERVALS OF 6 TO 8 WEEKS. THE DIAMETERS OF THE PD STENTS USED WERE THE FOLLOWING: 3F (15%), 5F (45%), 7F (38%), AND 10F (2%). OFF LABEL USE: TO TREAT FISTULA. ALTERING THE 3 FR STENT (CUT TO ADD INTERNAL FLAP. THIS FILE WILL CAPTURE THE OFF-LABEL USE (PANCREATIC STENT USED TO TREAT FISTULA, AND ALTERING THE 3 FR STENT (CUT TO ADD INTERNAL FLAP)) AND POTENTIAL FOR INJURY IN 92 OF 97 PATIENTS WHO DID NOT EXPERIENCE AN ADVERSE EVENT. STENT OCCLUSION CAPTURED IN A SEPARATE PR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086345 GEENEN PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male