BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 9984893 · Received April 22, 2020

    Report

    Report Number
    3001845648-2020-00248
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    March 24, 2020
    Report Date
    September 25, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002518527
    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/S006. DEVICE EVALUATION: THE ZFV6-125-10-10.0 DEVICE OF LOT NUMBER C1614394 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZFV6-125-10-10.0 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 (C1614394) 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 C1614394. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0058-4). "THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY(SFA) AND ABOVE THE KNEE." ROOT CAUSE REVIEW: A POSSIBLE ROOT CAUSE IS OFF LABEL USE. AS PER CUSTOMERS INFORMATION THE TARGET LOCATION WAS BILIARY. THE STENT WAS DEPLOYED IN AN AREA OF THE ANATOMY THAT IS NOT RECOMMENDED IN THE IFU AND MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE STENT FRACTURE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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 · 0

    STENT FRACTURE IN SIDE THE PATIENT. STENT DIDN'T DEPLOYED DURING THE PROCEDURE. 1. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES OR INTERVENTION? STENTING DONE IN LEFT SIDE ALTHOUGH UNILATERAL STENTING WAS PLANNED. PREFIX ZIV5/ZIV6/ZFV6: ANSWERS TO THE QUESTIONS ASKED: TARGET LOCATION: BILIARY. PERCUTANEOUS IPSILATERAL (RIGHT SIDED), ACCESS SITE OVER SKIN WAS IN RIGHT HYPOCHONDRIUM VIA 6 FR ARROW SHEATH, FLUSHED BOTH PORTS BEFORE DEPLOYMENT ULTRASTIFF AMPLATZULTRASTIFF AMPLATZ. ANATOMY WAS NORMAL, NO RESISTANCE WHILE PLACING WIRE AND DEVICE. PRE AND POST DILATATION NOT DONE. YES DEVICE CROSSED THE STRICTURE. YES ALL IMAGES AVAILABLE. YES IT WAS DEPLOYED VIA PULL TECHNIQUE, NO PUSHING DONE COVID NOT TESTED, ASYMPTOMATIC OTHERWISE. STENT FRACTURE DURING DEPLOYMENT: 1. WERE THERE ANY DIFFICULTIES DEPLOYING THE STENT- YES SOME UNDUE RESISTANCE DURING DEPLOYMENT , NEVER FELT BEFORE. 2. WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT YES WITH EXTREME DIFFICULTY DEPLOYED FULLY. 3. WAS THE TARGET SITE SEVERELY CALCIFIED / TORTUOUS ANATOMY - NO. 4. ARE ANGIOGRAPH/CT/X-RAY IMAGES AVAILABLE- YES.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    STENT FRACTURE IN SIDE THE PATIENT. STENT DIDN'T DEPLOYED DURING THE PROCEDURE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES OR INTERVENTION? STENTING DONE IN LEFT SIDE ALTHOUGH UNILATERAL STENTING WAS PLANNED. PREFIX ZIV5/ZIV6/ZFV6: ANSWERS TO THE QUESTIONS ASKED: TARGET LOCATION: BILIARY. PERCUTANEOUS IPSILATERAL (RIGHT SIDED), ACCESS SITE OVER SKIN WAS IN RIGHT HYPOCHONDRIUM VIA 6 FR ARROW SHEATH, FLUSHED BOTH PORTS BEFORE DEPLOYMENT ULTRASTIFF AMPLATZULTRASTIFF AMPLATZ. ANATOMY WAS NORMAL, NO RESISTANCE WHILE PLACING WIRE AND DEVICE. PRE AND POST DILATATION NOT DONE. YES DEVICE CROSSED THE STRICTURE. YES ALL IMAGES AVAILABLE. YES IT WAS DEPLOYED VIA PULL TECHNIQUE, NO PUSHING DONE. COVID NOT TESTED, ASYMPTOMATIC OTHERWISE. STENT FRACTURE DURING DEPLOYMENT: WERE THERE ANY DIFFICULTIES DEPLOYING THE STENT- YES SOME UNDUE REISTANCE DURING DEPLOYMENT , NEVER FELT BEFORE. WAS THE STENT FULLY DEPLOYED BEFORE REMOVING THE DELIVERY SYSTEM FROM THE PATIENT ¿ YES WITH EXTREME DIFFICULTY DEPLOYED FULLY. WAS THE TARGET SITE SEVERELY CALCIFIED / TORTUOUS ANATOMY - NO. ARE ANGIOGRAPH/CT/X-RAY IMAGES AVAILABLE- YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451474 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C1614394 10827002518527

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention