BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVALUATION BILIARY CONTROLLED-RELEASE STENT ¿ UNCOVERED

    MDR report key: 4608721 · Received March 12, 2015

    Report

    Report Number
    3001845648-2015-00052
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    September 13, 2014
    Report Date
    March 5, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT MEETS REPORTING CRITERIA BASED ON THE MEDICAL INTERVENTION CARRIED OUT (ANTIBIOTIC ADMINISTRATION) DUE TO THE OCCURRENCE OF CHOLECYSTITIS WHILE ON EVO DEVICE WAS INDWELLING. NO DEVICE MALFUNCTION HAS BEEN REPORTED. ON THE DAY OF THE PROCEDURE ((B)(6) 2014) THE BILIARY STRICTURE MEASURED 7 CM AND WAS LOCATED IN THE COMMON BILE DUCT. PRIOR TO STENT PLACEMENT A PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED. SPHINCTEROTOMY WAS PRE-EXISTING. A 10 MM X 8CM ((B)(4)) EVOLUTION BILIARY STENT, UNCOVERED WAS PLACED WITHOUT DIFFICULTY AT THE INTENDED LOCATION. THERE WAS NO PRE OR POST-STENT DILATION PERFORMED. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA. NO ADDITIONAL PROCEDURES WAS PERFORMED. ON (B)(6) 2014 (58 DAYS POST-PROCEDURE), THE PT WAS DIAGNOSED WITH CHOLECYSTITIS AND WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. THE SITE INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY PROCEDURE (WHEN EXPLANATION OF THE EVENT IS EQUALLY DUE TO PRODUCT/PROCEDURE OR OTHER CASE). THE SITE ALSO NOTED THAT PRE-EXISTING PANCREATIC CANCER ALSO CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE MARKED NO TO THE FOLLOWING QUESTION "DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE? ON (B)(6) 2014 ) 74 DAYS POST-PROCEDURE) THE PT EXPERIENCED SIGNS AND SYMPTOMS OF BILARY OBSTRUCTION. ENDOSCOPY REVEALED A 2 CM STRICTURE IN THE HILAR REGION, PROXIMAL (UPSTREAM) TO THE STUDY STENT. FOLLOWING BALLOON SWEEPS OF THE STUDY STENT, A NON-STUDY PLASTIC BILIARY STENT WAS PLACED AND IMMEDIATED DRAINAGE OF CONTRAST, DEBRIS AND BILE WAS NOTED. FOLLOWING PLACEMENT OF THE NON-STUDY STENT, THE PT EXITED THE STUDY. THE INFO PROVIDED IS CURRENTLY BEING INVESTIGATED" A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    PT IS INVOLVED IN POST MARKET STUDY: (B)(6); THE EVENT BEING REPORTED IS CHOLECYSTITIS. THE PT WAS HOSPITALIZED, TREATED WITH ANTIBIOTICS AND DISCHARGED 3 DAYS LATER. FOR FULL EVENT DESCRIPTION PLEASE REF "ADDITION INFO" SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169788 EVALUATION BILIARY CONTROLLED-RELEASE STENT ¿ UNCOVERED CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C902089

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention