BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 9191379 · Received October 15, 2019

    Report

    Report Number
    3001845648-2019-00523
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 12, 2019
    Report Date
    November 13, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002372709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K182980. DEVICE EVALUATION: THE ZIB6-40-8-6.0 DEVICE OF LOT NUMBER C1618653 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. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 17 OCTOBER 2019. ON EVALUATION OF THE DEVICE IT WAS OBSERVED THAT APPROX. 1.9 CM OF THE STENT WAS PARTIALLY DEPLOYED UPON RETURN. THE RED SAFETY TAB WAS NOT RETURNED WITH THE DEVICE. THERE WAS NO DAMAGE ON THE OUTER SHEATH OR DISTAL TIP OF THE DEVICE. THE DEVICE FLUSHED (THROUGH THE HUB AND SIDE-ARM FLUSHING PORT) AND WIRED (WITH A 0.035¿ WIRE GUIDE) AS EXPECTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIB6-40-8-6.0 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 ZIB6-40-8-6.0 OF LOT NUMBER C1618653 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 C1618653. THE INSTRUCTIONS FOR USE (IFU0040-6) INSTRUCTS THE USER TO ¿ENSURE THAT THE RED SAFETY LOCK IS NOT INADVERTENTLY REMOVED UNTIL FINAL STENT RELEASE.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: 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 (REF ATT. '(B)(4) IMAGING REVIEW VER2'): IMPRESSION: BECAUSE IMAGING OF THE COMPLAINT STENT WAS NOT PROVIDED, CONFIRMATION OF PREMATURE STENT DEPLOYMENT CANNOT BE CONFIRMED. THE IMAGING DEMONSTRATES STENT IMPLANTATION THROUGH A 2CM STENOSIS LOCATED JUST INFERIOR A PRE-EXISTING STENT. THE NEWLY IMPLANTED STENT REPRESENTED THE SECOND STENT IN COMPLAINT REPORT. BECAUSE IT WAS SUBJECTIVELY STRETCHED, THE 7CM LONG STENT LIKELY WAS AN 8X60MM STENT. CONSTRAINT OF THE SUCCESSFULLY IMPLANTED STENT BY THE 2CM LONG STENOSIS DEMONSTRATED THAT THE STENOSIS WAS AT LEAST MODERATE TO SEVERE AND PERSISTENT. IT HAD THE POTENTIAL TO SIGNIFICANTLY RESIST SHEATH ADVANCEMENT RELATIVE TO INNER CANNULA ADVANCEMENT. THIS COULD HAVE CAUSED THE COMPLAINT STENT TO PREMATURELY DEPLOY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DIFFICULT PATIENT ANATOMY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE TARGET LESION WAS PARTLY OBSTRUCTED AND HEAVILY STENOSED. IT IS POSSIBLE THAT THIS OBSTRUCTION RESULTED IN COMPRESSION OF THE OUTER SHEATH DURING ADVANCEMENT OF THE DEVICE RESULTING IN PARTIAL PREMATURE DEPLOYMENT OF THE STENT AND SUBJECTIVE STRETCHING OF THE REPLACEMENT STENT. IT IS ALSO POSSIBLE THAT THE RED SAFETY LOCK WAS INADVERTENTLY DISPLACED DURING ADVANCEMENT AS IT WAS NOT RETURNED WITH THE DEVICE. THE CUSTOMER COULD NOT RECALL WHAT HAPPENED TO THE RED SAFETY LOCK BUT DOES NOT RECALL REMOVING IT (REF. ATT. ¿PR 278130_RESPONSE TO QUERY RE RED SAFETY LOCK POST LAB¿). SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, A REPLACEMENT DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE AND 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

    THE STENT DEPLOYED ABOUT 0.2CM IN ADVANCE DURING THE PROCESS OF DELIVERY. THE STENT HAVE NOT DELIVERED TO THE TARGET LOCATION. THEN THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW STENT TO FINISHED THE PROCEDURE. DETAIL PROCESS OF THE PROCEDURE AND ADDITIONAL INFORMATION WILL BE UPDATED LATER. I AM ASKING THE DISTRIBUTOR COLLECT THESE INFO ASAP-(B)(6) FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    THE STENT DEPLOYED ABOUT 0.2CM IN ADVANCE DURING THE PROCESS OF DELIVERY. THE STENT HAVE NOT DELIVERED TO THE TARGET LOCATION. THEN THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW STENT TO FINISHED THE PROCEDURE. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K182980. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE STENT DEPLOYED ABOUT 0.2CM IN ADVANCE DURING THE PROCESS OF DELIVERY. THE STENT HAVE NOT DELIVERED TO THE TARGET LOCATION. THEN THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND REPLACED ANOTHER NEW STENT TO FINISHED THE PROCEDURE. DETAIL PROCESS OF THE PROCEDURE AND ADDITIONAL INFORMATION WILL BE UPDATED LATER. I AM ASKING THE DISTRIBUTOR COLLECT THESE INFO ASAP-(B)(6). (B)(6) 2019. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE¿. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985040 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C1618653 10827002372709

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR