BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 10734628 · Received October 26, 2020

    Report

    Report Number
    3005580113-2020-00435
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    November 20, 2004
    Report Date
    October 26, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: FGE CATHETER, BILIARY, DIAGNOSTIC.

    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, (B)(4)) 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). STENT OCCLUSION (5 PATIENTS): IN 5 PATIENTS, THE STENT WAS OCCLUDED AT REMOVAL. IN TWO, THERE WAS RESOLUTION OF THE DUCT DISRUPTION, BUT PERSISTENT DISRUPTION IN THE OTHER 3 NECESSITATED SURGERY. IN 3 PATIENTS, THE PANCREATIC STENT WAS OCCLUDED AT REMOVAL 8 WEEKS LATER. IN ONE PATIENT WITH AN OCCLUDED STENT, THE DUCT LEAK (BODY OF PANCREAS) WAS STILL PRESENT AND A NEW LEAK HAD DEVELOPED IN THE REGION OF THE TAIL; DISTAL PANCREATECTOMY WAS PERFORMED, AND THE PATIENT WAS DOING WELL AT 6 MONTHS¿ FOLLOW-UP. IN TWO OTHER PATIENTS WITH OCCLUDED STENTS, THE DUCT LEAK AT THE GENU HAD RESOLVED; BOTH WERE WELL AT THE 18 MONTHS¿ FOLLOW-UP. IN TWO PATIENTS, PUS WAS SEEN TO FLOW FROM THE PD ORIFICE AT STENT REMOVAL. BOTH HAD OCCLUDED STENTS (5F AND 7F, RESPECTIVELY); IN ONE, A PANCREATICOCUTANEOUS FISTULA WAS STILL PRESENT, AND, IN THE OTHER, THE DUCTAL LEAK IN THE BODY HAD WORSENED. BOTH PATIENTS UNDERWENT PANCREATIC DEBRIDEMENT. AT 3 MONTHS AFTER SURGERY, ONE PATIENT WAS DOING WELL AND THE OTHER HAD A PERCUTANEOUS DRAIN THAT WAS PLACED UNDER RADIOLOGIC GUIDANCE FOR A RECURRENT PFC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199387 GEENEN PANCREATIC STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention