BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

    MDR report key: 9642377 · Received January 29, 2020

    Report

    Report Number
    3001845648-2020-00060
    Event Type
    Injury
    Date Received
    January 29, 2020
    Date of Event
    April 26, 2019
    Report Date
    January 29, 2020
    Manufacturer
    COOK INC
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CANCELLATION REPORT. THIS COMPLAINT WAS PREVIOUSLY CAPTURED IN MDR 3001845648-2019-00596. THIS IS REPORT IS A DUPLICATION AND IS NO LONGER REQUIRED. AS THE EXACT RPN IS NOT KNOWN FOR THIS COMPLAINT, THE MOST LIKELY US CLEARANCE NUMBER IS : K121430.

    Description of Event or Problem · 0

    THIS IS A CANCELLATION REPORT. THIS COMPLAINT WAS PREVIOUSLY CAPTURED IN MDR 3001845648-2019-00596. THIS IS REPORT IS A DUPLICATION AND IS NO LONGER REQUIRED. LITERATURE REVIEW TITLE: '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019 OBJECTIVES OF THIS STUDY WERE EVALUATION OF SURVIVAL AND STENTS PATENCY AFTER PLACEMENT OF MULTIPLE SEMS FOR PALLIATION OF COMPLEX MHBS. WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOK ENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT . AS PER LITERATURE REVIEW: TABLE 1 SHOWS RE-INTERVENTIONS FOR OCCLUDED SEMS 55 OF 134 PATIENTS (I.E. 41%) ''55 PATIENTS RETURNED TO OUR ATTENTION WITH CLINICAL SIGNS OF SEMS OBSTRUCTION AND WERE RE-TREATED. FIFTY-FIVE (41%) PATIENTS EXPERIENCED ONE OR MORE EPISODES OF SEMS OBSTRUCTION. MOSTLY SEMS WERE CLOGGED BY SLUDGE, WHICH WAS FOUND IN 65.9% OF THE RE-INTERVENTIONS, ASSOCIATED WITH OVERGROWTH AND INGROWTH 34.1% OF THE CASES. THIS FILE IS BEING CREATED TO CAPTURE 55 CASES OF OVERGROWTH AND INGROWTH REQUIRING RE INTERVENTION BY PLACING AN UNCOVERED ¿BRIDGING¿ SEMS INSIDE THE PREVIOUS ONE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THIS IS A CONSERVATIVE ASSESSMENT - WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, (B)(4)), NITI-S (TAEWOONG MEDICAL INC (B)(4)) AND EVOLUTION (COOK ENDOSCOPY (B)(4)) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THE EXACT RPN IS UNKNOWN THEREFORE THE MOST LIKELY COMMON NAME FOR THIS IS FGE - COOK EVOLUTION BILIARY STENT AND K121430 IS THE MOST LIKELY 510 K #.

    Description of Event or Problem · 1

    LITERATURE REVIEW TITLE: '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019 OBJECTIVES OF THIS STUDY WERE EVALUATION OF SURVIVAL AND STENTS PATENCY AFTER PLACEMENT OF MULTIPLE SEMS FOR PALLIATION OF COMPLEX MHBS. WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, (B)(4)), NITI-S (TAEWOONG MEDICAL INC (B)(4)) AND EVOLUTION (COOK ENDOSCOPY, (B)(4)) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT . AS PER LITERATURE REVIEW: TABLE 1 SHOWS RE-INTERVENTIONS FOR OCCLUDED SEMS 55 OF 134 PATIENTS (I.E. 41%) ''55 PATIENTS RETURNED TO OUR ATTENTION WITH CLINICAL SIGNS OF SEMS OBSTRUCTION AND WERE RE-TREATED. FIFTY-FIVE (41%) PATIENTS EXPERIENCED ONE OR MORE EPISODES OF SEMS OBSTRUCTION. MOSTLY SEMS WERE CLOGGED BY SLUDGE, WHICH WAS FOUND IN 65.9% OF THE RE-INTERVENTIONS, ASSOCIATED WITH OVERGROWTH AND INGROWTH 34.1% OF THE CASES. THIS FILE IS BEING CREATED TO CAPTURE 55 CASES OF OVERGROWTH AND INGROWTH REQUIRING RE INTERVENTION BY PLACING AN UNCOVERED ¿BRIDGING¿ SEMS INSIDE THE PREVIOUS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104811 FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1