BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    MDR report key: 6882059 · Received September 21, 2017

    Report

    Report Number
    3001845648-2017-00406
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 24, 2017
    Report Date
    September 21, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002360485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K050698 AND K163169. 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 PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE PHYSICIAN DEPLOYED THE STENT AND AFTER DEPLOYMENT, THEY WENT TO PLACE THE BALLOON; HOWEVER, THEY REALIZED THE STENT PLACED WAS THE INCORRECT SIZE FROM WHAT THE PACKAGING SAID. SHOULD HAVE BEEN A 5.0-80 BUT WAS A 5.0-100. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE STENT SUCCESSFULLY. CONSERVATIVE INTERPRETATION OF 'STENT ELONGATION' UNTIL CLARIFICATION IS RECEIVED; INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K050698 AND K163169. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONCLUSION OF THIS INVESTIGATION. THE ZIB5-125-5.0-80 DEVICE OF LOT NUMBER C1269790 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: A SINGLE, POOR QUALITY IMAGE OF A ZILVER STENT IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY IS PROVIDED ALONG THE COMPLAINT REPORT. AN ANGIOPLASTY BALLOON WAS EXPANDED IN THE MID AND DISTAL STENT. THE DISTAL MARKERS LIKELY BELONG TO THE STENT. A MEASURING LINE, EXTENDED TO ILLUSTRATE THE LONGER THAN EXPECTED LENGTH OF THE STENT, EXTENDS BETWEEN EACH MARKER. IF THE MARKER WAS FROM A SECOND MORE INFERIOR STENT, THE OVERLAP OF TWO STENTS WOULD HAVE BEEN PRESENT AND THIS WAS MOST LIKELY ABSENT. THE MEASURED LENGTH OF THE STENT WAS MEASURED AS 101.63MM ON THE FILM. NO CALIBRATION SOURCE WAS ON THE FILM. THE DIAMETER OF THE ANGIOPLASTY BALLOON WAS NOT PROVIDED BUT WAS 4MM OR 5MM. BASED ON A 4MM BALLOON DIAMETER, THE STENT LENGTH WAS 88MM. BASED ON A 5MM BALLOON DIAMETER, THE STENT LENGTH WAS 113MM. INDIVIDUAL STENT ELEMENTS COULD NOT BE RESOLVED. IMPRESSION: A LONGER THAN LABELED STENT CANNOT BE CONFIRMED FOR TWO REASONS. FIRST, ALTHOUGH THE STENT WAS DEPICTED AS A 100MM LONG STENT, THE ACCURACY OF THIS MEASUREMENT IS QUESTIONABLE GIVEN THE DIFFERENT MEASUREMENTS OBTAINED WHEN CALIBRATING FROM THE LIKELY BALLOON DIAMETERS. IF NO INTERNAL CALIBRATION IS PERFORMED, SUPERFICIAL FEMORAL ARTERY MEASUREMENTS PERFORMED WITH AUTOMATIC CALIBRATION ARE USUALLY MAGNIFIED 10-15% FROM THE ACTUAL MEASUREMENT. SECOND, LONGITUDINAL STRETCHING OF THE STENT CANNOT BE EXCLUDED. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE NOT OBSERVED. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. ON EVALUATION OF THE RETURNED PACKAGING, IT WAS NOTED THAT THE PACKAGING WAS THE MARKETING BOX FOR THE COMPLAINT DEVICE. THERE WAS NO DEVICE OR DEVICE PORTION RETURNED WITH THE PACKAGING. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE IMAGE REVIEW, THE COMPLAINT STENT WAS IMPLANTED IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY. THE USE OF THE DEVICE IN A NON-INDICATED LOCATION COULD HAVE CAUSED OR CONTRIBUTED TO THE APPARENT STENT ELONGATION. AS PER THE PRODUCT INSTRUCTIONS FOR USE: "THE ZILVER 518 AND 635 BILIARY STENTS ARE INTENDED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE." A REVIEW OF THE RELEVANT MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED TO DATE, THERE IS NO EVIDENCE TO SUGGEST ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1269790. 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 · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: THE PHYSICIAN DEPLOYED THE STENT AND AFTER DEPLOYMENT, THEY WENT TO PLACE THE BALLOON; HOWEVER, THEY REALIZED THE STENT PLACED WAS THE INCORRECT SIZE FROM WHAT THE PACKAGING SAID. SHOULD HAVE BEEN A 5.0-80 BUT WAS A 5.0-100. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE STENT SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664282 ZILVER 518 BILIARY SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G36048 10827002360485

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR