BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    MDR report key: 7263548 · Received February 12, 2018

    Report

    Report Number
    3001845648-2018-00050
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 12, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    00827002543263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) # K051124 / K163169. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K051124 / K163169. PROBLEM STATEMENT: ¿THE COOK STENT AS WELL AS A BOSTON SCIENTIFIC WALL STENT 12X40 HAD MIGRATED TO THE LEFT ATRIUM. PATIENT HAD TO UNDERGO OPEN HEART SURGERY AND THE STENTS WERE REMOVED AND PATIENT IS DOING FINE AT THIS POINT. ¿ ¿NO ULTRASOUND OR IVIZ WAS USED TO MEASURE ILIAC VEINS.¿ DEVICE EVALUATION: THE ZIB6-125-14.0-80 OF LOT NUMBER C1314532 DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT NO SECTION OF THE COMPLAINT DEVICE REMAINED IN THE PATIENT¿S BODY. PATIENT REQUIRED ADDITIONAL PROCEDURE, OPEN HEART SURGERY IN ORDER TO REMOVE THE STENT. THE COMPLAINT DEVICE CONTRIBUTED THE ADDITIONAL PROCEDURE DUE TO STENT MIGRATION. THE COMPLAINT DEVICE UNDERWENT A LABORATORY EVALUATION ON THE 15 FEBRUARY 2018. ON EVALUATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT ONLY DEVICE STENT RETURNED. THERE WAS EVIDENCE OF STENT FRACTURE ALONG LENGTH, POSSIBLY DUE TO THE SURGERY TO REMOVE STENT. IT WAS FOUND THAT THE STENT WAS COVERED IN BLOOD AND TISSUE ON THE STENT. IT WAS NOTED THAT THE STENT LENGTH WAS APPROXIMATELY 8 CM. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER: THE TARGET LOCATION FOR THE DEVICE. AFTER THREE REQUESTS, THE INFORMATION WAS NOT PROVIDED. THE INVESTIGATION WILL BE UPDATED IF THE INFORMATION BECOMES AVAILABLE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF THE DEVICE IN A NON-INDICATED LOCATION. THE CUSTOMER REPORTED THAT THE ZIB6 (ZILVER BILIARY) STENT WAS IMPLANTED IN THE ILIAC VEIN. THE NON-INDICATED LOCATION COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT MIGRATION. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE PRODUCT IFU: "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE¿. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE IF THIS EVENT CANNOT BE DETERMINED. DOCUMENT REVIEW: A REVIEW OF THE INCOMING QC INSPECTION RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRIOR TO DISTRIBUTION, ALL ZIB6 (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT REQUIRED OPEN HEART SURGERY TO REMOVE THE MIGRATED STENT. THE RISK ASSOCIATED WITH THE COMPLAINT IS RISK CATEGORY I/HIGH RISK LEVEL. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE COOK STENT AS WELL AS A BOSTON SCIENTIFIC WALL STENT 12X40 HAD MIGRATED TO THE LEFT ATRIUM. PATIENT HAD TO UNDERGO OPEN HEART SURGERY AND THE STENTS WERE REMOVED AND PATIENT IS DOING FINE AT THIS POINT. NO ULTRASOUND OR IVIZ WAS USED TO MEASURE ILIAC VEINS.

    Description of Event or Problem · 0

    THE COOK STENT AS WELL AS A BOSTON SCIENTIFIC WALL STENT 12X40 HAD MIGRATED TO THE LEFT ATRIUM. PATIENT HAD TO UNDERGO OPEN HEART SURGERY AND THE STENTS WERE REMOVED AND PATIENT IS DOING FINE AT THIS POINT. NO ULTRASOUND OR IVIZ WAS USED TO MEASURE ILIAC VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106947 ZILVER 635 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD 00827002543263

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R