BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 7955428 · Received October 11, 2018

    Report

    Report Number
    3001845648-2018-00481
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 11, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002438573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : P050017/S002 AND S003. 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.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : P050017/S002 AND S003. 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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: "AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN NOTED THAT THE DEVICE LOOKED SHORTER THAN EXPECTED UNDER FLUOROSCOPY UPON DEPLOYMENT."¿ DEVICE EVALUATION: THE ZIV6-35-80-8-60 DEVICE OF LOT NUMBER C1436925 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ADDITIONAL INFORMATION COOK IRELAND (CIRL) REQUESTED INFORMATION REGARDING THE STENT LENGTH ON THE 01ST, 05TH, 09TH AND 15TH OF OCTOBER 2018. THE SALES REP RESPONDED TO CIRL ON OCTOBER 16TH 2018 WITH THE FOLLOWING INFORMATION REGARDING THE COMPLAINT STENT. AFTER A FOLLOW UP WITH THE PHYSICIAN BY THE DISTRICT MANAGER, THE PHYSICIAN CONFIRMED HE DID NOT BELIEVE THE STENT WAS OF INCORRECT LENGTH. THE PHYSICIAN REMARKED THAT THE ASSISTANT SIZED THE PATIENT¿S VESSEL, CHOSE THE STENT LENGTH AND DEPLOYED THE STENT. THE PHYSICIAN COMMENTED THAT THE ASSISTANT ON THE CASE CHOSE THE INCORRECT STENT LENGTH AND THE DEVICE WAS NOT THE WRONG SIZE AND THERE WERE NO ISSUES WITH THE STENT AT ALL. THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS NOT DEFECTIVE AND IT WAS A CASE OF HUMAN ERROR ON THE ASSISTANT¿S BEHALF. THE COMPLAINT IS NOT CONFIRMED AS THERE WAS NO DEFECT WITH THE DEVICE. ROOT CAUSE: THE ROOT CAUSE FOR THIS COMPLAINT WAS ESTABLISHED AS HUMAN ERROR. THERE WAS NO DEFECT WITH THE STENT USED. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IFU REVIEW: IT MAY BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE CHOSEN STENT DIAMETER SHOULD BE AT LEAST 1 MM LARGER THAN THE DIAMETER OF THE REFERENCE VESSEL. DETERMINE THE PROPER STENT SIZE AFTER COMPLETE DIAGNOSTIC EVALUATION¿MEASURE THE LENGTH OF THE TARGET LESION TO DETERMINE THE LENGTH OF THE STENT REQUIRED. ALLOW FOR THE PROXIMAL AND DISTAL ASPECTS OF THE STENT TO COVER THE ENTIRE TARGET AREA.¿ DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZIV6 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1436925) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1436925. SUMMARY THE COMPLAINT IS NOT CONFIRMED AS THERE WAS NO DEFECT WITH THE DEVICE. 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

    AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN NOTED THAT THE DEVICE LOOKED SHORTER THAN EXPECTED UNDER FLUOROSCOPY UPON DEPLOYMENT."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS, "PHYSICIAN NOTED THAT THE DEVICE LOOKED SHORTER THAN EXPECTED UNDER FLUOROSCOPY UPON DEPLOYMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796029 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G43857 C1436925 10827002438573

    Patients

    Seq Age Sex Outcome Treatment
    1