BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 6710580 · Received July 13, 2017

    Report

    Report Number
    3001845648-2017-00268
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 9, 2017
    Report Date
    July 13, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506210
    PMA / PMN Number
    K020788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 THE ZILBS-635-10-6 DEVICE OF LOT NUMBER C1313704 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE STENT WAS NOT BROKEN, AND NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE STENT DID NOT PREMATURELY DEPLOY. THE CUSTOMER CONFIRMED THAT THE WHITE PLASTIC TIP OF THE DEVICE WAS DAMAGED. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE WALL OF A PREVIOUSLY PLACED STENT. ON EVALUATION OF THE RETURNED DEVICE, ¿FISH MOUTH¿ DAMAGE WAS OBSERVED ON THE DISTAL WHITE TIP, SUGGESTING THAT THE TIP CAUGHT ON AN OBSTRUCTION DURING ADVANCEMENT. DAMAGE WAS NOTED ON THE DISTAL END OF THE FLEXOR, AND THE DISTAL END OF THE FLEXOR WAS EXPOSED. THE STENT WAS SLIGHTLY MOVED INSIDE THE FLEXOR. THE ENGINEERS DEPLOYED THE STENT IN THE LAB, WITH NO ISSUES REPORTED. THE STENT WAS MEASURED TO BE 60MM IN LENGTH. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED INCORRECTLY. THE CUSTOMER COMPLAINT IS CONFIRMED AS DAMAGE WAS OBSERVED ON THE DISTAL END OF THE DEVICE FLEXOR AND ON THE DISTAL WHITE TIP. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE COMPLAINT DEVICE BECOMING OBSTRUCTED OR SNAGGING DURING ADVANCEMENT. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE PHYSICIAN HAD PREVIOUSLY DEPLOYED ANOTHER STENT, AND WAS ATTEMPTING TO ADVANCE THE COMPLAINT DEVICE THROUGH THE WALL OF THE PREVIOUSLY DEPLOYED STENT. THE COMPLAINT DEVICE MAY HAVE CAUGHT OR SNAGGED THE PREVIOUS STENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE DAMAGE OBSERVED ON THE DEVICE. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO IMPROVE THE STRENGTH OF THE OUTER FLEXOR. THE PRODUCT INSTRUCTION FOR USE STATES: "THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT.". PRIOR TO DISTRIBUTION ALL ZILBS (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS 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 TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1313704. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    TIP OF THE STENT WAS BROKEN AND IMPOSSIBLE TO USE. NO PART INTO THE PATIENT. NO PROBLEM FOR THE PATIENT. THEY FINISHED EXAMINATION WITH ANOTHER STENT FROM ANOTHER COMPANY. COMPLAINT DETAILS: CUSTOMER OPENED AND SEALED THE PACKAGE REMOVED THE STENT WITHOUT ANY PROBLEM. GUIDE WIRE WAS IN THE GOOD POSITION THROUGH A METALLIC STENT ALREADY IN THE PATIENT DR WANTED TO PLACE SECOND STENT THROUGH THE FIRST. THEY SLIDE THE STENT ON THE GUIDE WIRE WITHOUT PROBLEM BUT WHEN THEY TRIED TO PUT THE STENT INTO THE FIRST IT WAS DIFFICULT AND IMPOSSIBLE. THEY REMOVED THE STENT FROM THE SCOPE AND THEY SAW THAT TIP WAS DEFORMED AND OUT FROM THE PLASTIC CATHETER. THEY TRIED TO REPAIR THE STENT MANUALLY BUT THEY COULDN'T. THEY DECIDED TO TAKE A NEW ONE FROM ANOTHER COMPANY AND THEY FINISHED EXAMINATION WITHOUT PROBLEM FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SENT IN RELATION TO THIS EVENT. INITIAL ASSESSMENT WAS A CONSERVATIVE ASSESSMENT PENDING COMPLETION OF THE INVESTIGATION. RISK ANALYSIS HAS NOW BEEN COMPLETED AND THE OVERALL RISK HAS BEEN ASSESSED AS LOW. NO MEDICAL/SURGICAL INTERVENTION HAS BEEN REPORTED. THIS COMPLAINT DOES NOT MEET THE DEFINITION OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO PATIENT INJURY HAS BEEN REPORTED AND NO MALFUNCTION REPORTING PRECEDENCE'S EXIST FOR THIS TYPE OF EVENT FOR THIS DEVICE. INVESTIGATION DETAILS: THE (B)(4) DEVICE OF LOT NUMBER C1313704 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE STENT WAS NOT BROKEN, AND NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE STENT DID NOT PREMATURELY DEPLOY. THE CUSTOMER CONFIRMED THAT THE WHITE PLASTIC TIP OF THE DEVICE WAS DAMAGED. THE CUSTOMER CONFIRMED THAT THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE WALL OF A PREVIOUSLY PLACED STENT. ON EVALUATION OF THE RETURNED DEVICE, ¿FISH MOUTH¿ DAMAGE WAS OBSERVED ON THE DISTAL WHITE TIP, SUGGESTING THAT THE TIP CAUGHT ON AN OBSTRUCTION DURING ADVANCEMENT. DAMAGE WAS NOTED ON THE DISTAL END OF THE FLEXOR, AND THE DISTAL END OF THE FLEXOR WAS EXPOSED. THE STENT WAS SLIGHTLY MOVED INSIDE THE FLEXOR. THE ENGINEERS DEPLOYED THE STENT IN THE LAB, WITH NO ISSUES REPORTED. THE STENT WAS MEASURED TO BE 60MM IN LENGTH. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED INCORRECTLY. THE CUSTOMER COMPLAINT IS CONFIRMED AS DAMAGE WAS OBSERVED ON THE DISTAL END OF THE DEVICE FLEXOR AND ON THE DISTAL WHITE TIP. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE COMPLAINT DEVICE BECOMING OBSTRUCTED OR SNAGGING DURING ADVANCEMENT. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE PHYSICIAN HAD PREVIOUSLY DEPLOYED ANOTHER STENT, AND WAS ATTEMPTING TO ADVANCE THE COMPLAINT DEVICE THROUGH THE WALL OF THE PREVIOUSLY DEPLOYED STENT. THE COMPLAINT DEVICE MAY HAVE CAUGHT OR SNAGGED THE PREVIOUS STENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE DAMAGE OBSERVED ON THE DEVICE. IT MAY BE NOTED THAT A PROJECT HAS BEEN INITIATED TO IMPROVE THE STRENGTH OF THE OUTER FLEXOR. THE PRODUCT INSTRUCTION FOR USE STATES: "THE DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT.". PRIOR TO DISTRIBUTION ALL ZILBS (ZILVER BILIARY) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS 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 TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1313704. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SENT IN RELATION TO THIS EVENT. INITIAL ASSESSMENT WAS A CONSERVATIVE ASSESSMENT PENDING COMPLETION OF THE INVESTIGATION. RISK ANALYSIS HAS NOW BEEN COMPLETED AND THE OVERALL RISK HAS BEEN ASSESSED AS LOW. NO MEDICAL/SURGICAL INTERVENTION HAS BEEN REPORTED. THIS COMPLAINT DOES NOT MEET THE DEFINITION OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO PATIENT INJURY HAS BEEN REPORTED AND NO MALFUNCTION REPORTING PRECEDENCE'S EXIST FOR THIS TYPE OF EVENT FOR THIS DEVICE. INITIAL REPORT DETAILS: TIP OF THE STENT WAS BROKEN AND IMPOSSIBLE TO USE. NO PART INTO THE PATIENT. NO PROBLEM FOR THE PATIENT. THEY FINISHED EXAMINATION WITH ANOTHER STENT FROM ANOTHER COMPANY. COMPLAINT DETAILS: CUSTOMER OPENED AND SEALED THE PACKAGE REMOVED THE STENT WITHOUT ANY PROBLEM. GUIDE WIRE WAS IN THE GOOD POSITION THROUGH A METALLIC STENT ALREADY IN THE PATIENT DR WANTED TO PLACE SECOND STENT THROUGH THE FIRST. THEY SLIDE THE STENT ON THE GUIDE WIRE WITHOUT PROBLEM BUT WHEN THEY TRIED TO PUT THE STENT INTO THE FIRST IT WAS DIFFICULT AND IMPOSSIBLE. THEY REMOVED THE STENT FROM THE SCOPE AND THEY SAW THAT TIP WAS DEFORMED AND OUT FROM THE PLASTIC CATHETER. THEY TRIED TO REPAIR THE STENT MANUALLY BUT THEY COULDN'T. THEY DECIDED TO TAKE A NEW ONE FROM ANOTHER COMPANY AND THEY FINISHED EXAMINATION WITHOUT PROBLEM FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493297 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50621 10827002506210

    Patients

    Seq Age Sex Outcome Treatment
    1