BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 4293333 · Received November 24, 2014

    Report

    Report Number
    3001845648-2014-00264
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    April 25, 2013
    Report Date
    October 27, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022/S001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR STENT FRACTURE REGARDLESS OF PATIENT OUTCOME. THE LOT NUMBER OF THE FRACTURED ZILVER PTX STENT CANNOT BE DETERMINED THEREFORE A REPORT HAS BEEN SUBMITTED FOR BOTH SUSPECT ZILVER PTX DEVICES. THE INVESTIGATION BELOW RELATES TO STENT FRACTURE OF THE SUSPECTED DEVICE ZIV6-35-125-6.0-120-PTX, LOT NUMBER C780022. REFERENCE DIRECTLY RELATED REPORT 3001845648-2014-00263. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C780022 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. ANGIOGRAPHY IMAGES FROM STENT IMPLANTATION ((B)(6)2012) AND FOLLOW-UP RUNOFF ((B)(6)2013) WERE PROVIDED. IN RELATION TO STENT FRACTURE THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT IMAGE REVIEWER: "THE MID-SFA STENT WAS NARROWED BY NEE-INTIMAL HYPERPLASIA 50%, RESIDUAL LUMINAL DIAMETER OF 3 MM, JUST PROXIMAL A NEW MID-STENT 1MM STEP OFF...A NEW STEP-OFF DEVELOPED ON THE MID-SFA ZILVER PTX STENT MEDIAL ASPECT IN BETWEEN IMPLANTATION AND A 7 MONTH FOLLOW-UP. THE FRACTURE MOST LIKELY WAS A TYPE I FRACTURE. IMAGE QUALITY WAS INSUFFICIENT TO EXCLUDE A TYPE II FRACTURE. THIS FRACTURE WAS NOT ASSOCIATED WITH NEO- INTIMAL HYPERPLASIA....THE TOTAL STENTED LENGTH WAS 26.6 CM. SFA STENTED LENGTHS GREATER THAN 8 CM ARE AT INCREASED FRACTURE RISK. (J AM COLL CARDIOL. 2005; 45: 312-315.)" BASED ON THE IMAGES, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE FRACTURE MOST LIKELY WAS A TYPE I FRACTURE HOWEVER IMAGE QUALITY WAS INSUFFICIENT TO EXCLUDE A TYPE II FRACTURE. IT IS KNOWN THAT IN THIS CASE A TOTAL STENTED LENGTH WAS 26.6 CM. ACCORDING TO PUBLISHED LITERATURE STENTED LENGTHS GREATER THAN 8 CM ARE AT INCREASED FRACTURE RISK. IT'S THEREFORE POSSIBLE THAT THIS COULD BE ALSO A CONTRIBUTING FACTOR IN THIS CASE; HOWEVER A DEFINITIVE CAUSE OF STENT FRACTURE CANNOT BE DETERMINED. STENT STRUT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. PRIOR TO DISTRIBUTION ALL ZILVER PTX 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. ACCORDING TO INFORMATION PROVIDED, STENT FRACTURE HAD BEEN CONFIRMED APPROX. 6 MONTHS AGO BUT SINCE IT HAS NO EFFECT ON BLOOD FLOW NO ADDITIONAL INTERVENTION HAS BEEN CONDUCTED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, FRACTURE (TYPE I) WAS CONFIRMED IN THE MIDDLE OF EITHER ZIV6-35-125-6.0-120-PTX/C781683 OR ZIV6-35-125-6.0-120-PTX/C780022. INSPECTION OF PAST IMAGES INDICATED STENT FRACTURE WAS OVERLOOKED BY THE PHYSICIAN IN IMAGING DATED (B)(6) 2014. NO ADDITIONAL INTERVENTION HAS BEEN TAKEN BECAUSE THE FRACTURE HAS NOT BECOME WORSE SINCE (B)(6) 2013. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND ON-GOING FOLLOW-UP IS PROVIDED. THE LOT NUMBER OF THE FRACTURED ZILVER PTX STENT CANNOT BE DETERMINED THEREFORE A REPORT HAS BEEN SUBMITTED FOR BOTH SUSPECT ZILVER PTX DEVICES. THIS REPORT RELATES TO STENT FRACTURE OF THE SUSPECTED DEVICE ZIV6-35-125-6.0-120-PTX, LOT NUMBER C780022. REFERENCE DIRECTLY RELATED REPORT 3001845648-2014-00263. NOTE RESTENOSIS HAS ALSO BEEN REPORTED WITH THIS PATIENT WITH THESE DEVICES. REFERENCE MDR REPORTS 3001845648-2014-00260, 3001845648-2014-00261 AND 3001845648-2014-00262. ON (B)(6) 2014: THE PATIENT HAD A FAVOURABLE OUTCOME. NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763289 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU SENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C780022

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR