BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 9489562 · Received December 18, 2019

    Report

    Report Number
    3001845648-2019-00746
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    December 23, 2016
    Report Date
    January 11, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    K162717 - EXACT RPN NOT KNOWN, THIS IS THE MOST LIKELY US CLEARANCE NUMBER. DEVICE EVALUATION: THE EVO DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. A TOTAL OF TWENTY FIVE PATIENTS WERE IDENTIFIED IN THIS RETROSPECTIVE STUDY OF 35 PROCEDURES OVER AN 8-YEAR PERIOD. THE STENTS USED WERE AS FOLLOWS: 11ENDOMAXX (MERIT), 11 WALLFLEX (BOSTON SCIENTIFIC), 5 POLYFLEX (BOSTON SCIENTIFIC), AND 3 EVOLUTION COOK ENDOSCOPY) WERE USED. THIS FILE CAPTURES STENT MIGRATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO STENT IS UNKNOWN DEVICE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (PARTIALLY AND FULLY COVERED ESOPHAGEAL STENT) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0061-6, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : PERFORATION, HEMORRHAGE, ASPIRATION, REFLUX, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATION INCLUDE, BUT ARE NOT LIMITED TO: STENT MISPLACEMENT AND/OR MIGRATION; TUMOR INGROWTH OR OVERGROWTH; ESOPHAGEAL ULCERATION AND EROSION; NAUSEA; CHEST OR RETROSTERNAL PAIN; FOREIGN BODY SENSATION; FOOD BOLUS IMPACTION; GASBLOAT; SENSITIVITY TO METAL COMPONENTS; FISTULA INVOLVING TRACHEA, BRONCHI OR PLEURAL SPACE; INTESTINAL OBSTRUCTION SECONDARY TO MIGRATION; MEDIASTINITIS OR PERITONITIS; AIRWAY COMPRESSION; TRACHEAL OBSTRUCTION. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT MISPLACEMENT AND/OR MIGRATION ARE LISTED AS A POTENTIAL COMPLICATION FOLLOWING THE PLACEMENT OF THIS DEVICE. SUMMARY: CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. 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 COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    K162717 - EXACT RPN NOT KNOWN, THIS IS THE MOST LIKELY US CLEARANCE NUMBER. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 03DEC2019. SILON ET AL 2017-"ENDOSCOPIC MANAGEMENT OF ESOPHAGORESPIRATORY FISTULAS: A MULTICENTER RETROSPECTIVE STUDY OF TECHNIQUES AND OUTCOMES". AS REPORTED TO CUSTOMER RELATIONS: STENT MIGRATION WITH SUBSEQUENT ASPIRATION AND 5 CASES OF STENT MIGRATION WITH NO REPORTED INTERVENTION. THE INDICATION FOR REPEAT PROCEDURES WAS REPOSITIONING OF THE ESOPHAGEAL STENT AFTER STENT MIGRATION WITH RECURRENT ASPIRATION IN ONE CASE. REPEAT PROCEDURES ALSO UTILIZED ESOPHAGEAL STENTS COMBINED WITH AIRWAY STENTS AND DID NOT ACHIEVE CLINICAL SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285576 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN
    1285577 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention