BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 9294850 · Received November 8, 2019

    Report

    Report Number
    3001845648-2019-00583
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    October 12, 2019
    Report Date
    December 6, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002372914
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: P050017/S002 AND S003. DEVICE EVALUATION: THE ZIV6-80-14-8.0 DEVICE OF LOT NUMBER: C1557651 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A-DEVICE DID NOT RETURN. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZIV6-80-14-8.0 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 RELEVANT MANUFACTURING RECORDS (C1557651) 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 C1557651. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0041-7). ¿THIS PRODUCT IS INTENDED FOR USE IN THE ILIAC ARTERIES¿. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO OFF LABEL USE, AS THE DEVICE WAS USED IN THE BILIARY SYSTEM. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, A SECOND STENT WAS PLACED INSIDE THE FRACTURED STENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    POST DEPLOYMENT BALLOON DILATION SHOWED FRACTURE OF THE STENT.

    Description of Event or Problem · 0

    POST DEPLOYMENT BALLOON DILATION SHOWED FRACTURE OF THE STENT. 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 ANOTHER STENT WAS PLACED WITHIN THE FRACTURED STENT ALSO REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS

    Description of Event or Problem · 1

    POST DEPLOYMENT BALLOON DILATION SHOWED FRACTURE OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092410 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C1557651 10827002372914

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention