BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 8235354 · Received January 10, 2019

    Report

    Report Number
    3001845648-2019-00015
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 10, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = P100022/S014. 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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = P100022/S014. 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. DEVICE EVALUATION: THE ZISV6-35-125-6-60-PTX DEVICE OF LOT NUMBER C1480755 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZISV6-35-125-6-60-PTX DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZISV6-35-125-6-60-PTX OF LOT NUMBER C1480755 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1480755. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿A 0.035 INCH (0.89MM) DIAMETER WIRE GUIDE SHOULD BE USED DURING TRACKING, DEPLOYMENT, AND REMOVAL IN ORDER TO ENSURE ADEQUATE SUPPORT OF THE SYSTEM. IF HYDROPHILIC WIRE GUIDES ARE USED, THEY MUST BE KEPT FULLY ACTIVATED.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF RETRACTION WIRE SEPARATION AS A RESULT OF USER ERROR WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT A NON-RECOMMENDED WIRE GUIDE WAS USED WITH THE DEVICE. IT IS POSSIBLE THAT THIS RESULTED IN INSUFFICIENT DEVICE SUPPORT DURING ADVANCEMENT AND/OR ATTEMPTED DEPLOYMENT. INSUFFICIENT DEVICE SUPPORT MAY HAVE CAUSED AND/OR CONTRIBUTED TO HIGHER DEPLOYMENT FORCES RESULTING IN SEPARATION OF THE RETRACTION WIRE FROM THE STENT RETRACTION SHEATH (SRS). SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING DEPLOYMENT OF THE STENT IN THE PROXIMAL POPLITEAL, WHEN THE STENT WAS APPROXIMATELY A QUARTER OF THE WAY DEPLOYED, THE THUMB WHEEL BROKE. THE USER ATTEMPTED TO CRACK OPEN THE HANDLE TO MANUALLY DEPLOY THE STENT, BUT THIS WAS UNSUCCESSFUL. THE USER PULLED BACK ON THE SYSTEM AND THE STENT DEPLOYED. THE STENT DEPLOYED INSIDE PREVIOUSLY PLACED STENT, WHICH WAS NOT THE INTENDED TARGET LOCATION FOR THE STENT PLACEMENT. THE USER BALLOONED THE STENT TO SECURE IT AND THEN PROCEED TO PLACE A ZILVER 518 TO COMPLETE THE INTENDED PROCEDURE.

    Description of Event or Problem · 0

    DURING DEPLOYMENT OF THE STENT IN THE PROXIMAL POPLITEAL, WHEN THE STENT WAS APPROXIMATELY A QUARTER OF THE WAY DEPLOYED, THE THUMB WHEEL BROKE. THE USER ATTEMPTED TO CRACK OPEN THE HANDLE TO MANUALLY DEPLOY THE STENT, BUT THIS WAS UNSUCCESSFUL. THE USER PULLED BACK ON THE SYSTEM AND THE STENT DEPLOYED. THE STENT DEPLOYED INSIDE PREVIOUSLY PLACED STENT, WHICH WAS NOT THE INTENDED TARGET LOCATION FOR THE STENT PLACEMENT. THE USER BALLOONED THE STENT TO SECURE IT AND THEN PROCEED TO PLACE A ZILVER 518 TO COMPLETE THE INTENDED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29458 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G38479 C1480755 10827002384795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention