BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 8964943 · Received September 5, 2019

    Report

    Report Number
    3001845648-2019-00453
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 6, 2019
    Report Date
    December 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P100022/S026. DEVICE EVALUATION THE ZISV6-35-125-7-140-PTX DEVICE OF LOT NUMBER C1557555 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. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZISV6-35-125-7-140-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 ZISV6-35-125-7-140-PTX OF LOT NUMBER C1557555 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 C1557555. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0118-4) INSTRUCTS THE USER TO ¿ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH.¿ THERE IS EVIDENCE TO SUGGEST THAT THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. 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. IMPRESSION THE ZISV6-35-125-7-140-PTX WAS FIRST IMPLANTED CONCERTINAED, THEN STRETCHED, AND FINALLY NORMALLY. BECAUSE OF THE SHORT SHEATH, ANTEGRADE ACCESS, AND PROXIMAL SFA LOCATION, THE STABILITY SHEATH WOULD HAVE BEEN OUTSIDE THE ACCESS SHEATH. UPON INITIAL DEPLOYMENT, DEPLOYMENT SHEATH RETRACTION WOULD HAVE ADVANCED THE STENT. THIS EXPLAINS THE CONCERTINAED DISTAL STENT AND IMPRESSION THAT THE DELIVERY SYSTEM WAS STUCK IN THE ACCESS SHEATH. WITH THE APPLICATION OF COUNTERING TRACTION, THE MID STENT WAS STRETCHED. THE FINAL SEGMENT DEPLOYED WITH BALANCED TRACTION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER THE IMAGING REVIEW A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL END OF THE STABILITY SHEATH BEING OUTSIDE OF THE ACCESS SHEATH DURING DEPLOYMENT AND THE ATTEMPT BY THE USER TO COUNTERACT THE TRACTION DURING DEPLOYMENT. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). ACCORDING TO THE INITIAL REPORTER, AN ADDITIONAL STENT WAS PLACED TWO HOURS AFTER THE ZILVER PTX STENT BECAME STRETCHED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S026. DEVICE EVALUATION: THE ZISV6-35-125-7-140-PTX DEVICE OF LOT NUMBER C1557555 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. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZISV6-35-125-7-140-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 ZISV6-35-125-7-140-PTX OF LOT NUMBER C1557555 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 C1557555. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0118-4) INSTRUCTS THE USER TO ¿ENSURE THE DISTAL END OF THE STABILITY SHEATH IS INSIDE THE ACCESS SHEATH.¿ THERE IS EVIDENCE TO SUGGEST THAT THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. 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 VER1'): IMPRESSION: THE ZISV6-35-125-7-140-PTX WAS FIRST IMPLANTED CONCERTINAED, THEN STRETCHED, AND FINALLY NORMALLY. BECAUSE OF THE SHORT SHEATH, ANTEGRADE ACCESS, AND PROXIMAL SFA LOCATION, THE STABILITY SHEATH WOULD HAVE BEEN OUTSIDE THE ACCESS SHEATH. UPON INITIAL DEPLOYMENT, DEPLOYMENT SHEATH RETRACTION WOULD HAVE ADVANCED THE STENT. THIS EXPLAINS THE CONCERTINAED DISTAL STENT AND IMPRESSION THAT THE DELIVERY SYSTEM WAS STUCK IN THE ACCESS SHEATH. WITH THE APPLICATION OF COUNTERING TRACTION, THE MID STENT WAS STRETCHED. THE FINAL SEGMENT DEPLOYED WITH BALANCED TRACTION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD OF USE ERROR WAS DETERMINED FROM THE AVAILABLE INFORMATION. AS PER THE IMAGING REVIEW A ROOT CAUSE COULD BE ATTRIBUTED TO THE DISTAL END OF THE STABILITY SHEATH BEING OUTSIDE OF THE ACCESS SHEATH DURING DEPLOYMENT AND THE ATTEMPT BY THE USER TO COUNTERACT THE TRACTION DURING DEPLOYMENT. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). ACCORDING TO THE INITIAL REPORTER, AN ADDITIONAL STENT WAS PLACED TWO HOURS AFTER THE ZILVER PTX STENT BECAME STRETCHED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS, "WHEN ATTEMPTING TO DEPLOY THE STENT, ANTEGRADE AND IPSILATERAL. THE STENT ELONGATED ABOUT 90MM'S. DUE TO THE DELIVERY SYSTEM GETTING CAUGHT IN THE VALVE ON THE SHORT SHEATH. THEY BROUGHT THE PATIENT 2 HOURS LATER AS THE FACILITY DECIDED THEY NEEDED TO PUT ANOTHER STENT IN TO COVER THE ELONGATED ZILVER PTX." FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS SECONDARY INTERVENTION WAS REQUIRED. ALSO REPORTABLE BASED ON "STENT ELONGATION" PRECEDENCE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE A CORRECTION TO THE ANNEX C CODE AND ROOT CAUSE COMPLETE ON 14-DEC-2023.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P100022/S026. 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.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS, "WHEN ATTEMPTING TO DEPLOY THE STENT, ANTEGRADE AND IPSILATERAL. THE STENT ELONGATED ABOUT 90MM'S. DUE TO THE DELIVERY SYSTEM GETTING CAUGHT IN THE VALVE ON THE SHORT SHEATH. THEY BROUGHT THE PATIENT 2 HOURS LATER AS THE FACILITY DECIDED THEY NEEDED TO PUT ANOTHER STENT IN TO COVER THE ELONGATED ZILVER PTX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760030 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD G38491 C1557555 10827002384917

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention