BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG - ELUTING PERIPHERAL STENT

    MDR report key: 3925524 · Received June 18, 2014

    Report

    Report Number
    3001845648-2014-00106
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    February 6, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/5109K: P100022 AND S001. THIS COMPLAINT EVENT IS FDA MDR REPORTABLE BASED ON THE INTERVENTION PERFORMED ON THE (B)(4) 2014 (PTA IN THE RIGHT SFA) DUE TO THE RE-OCCLUSION OF THE LESION WHILE A ZILVER PTX STENT WAS INDWELLING. THE DEVICE INVOLVED IN THIS COMPLAINT IS: 1X ZIV6-35-125-6.0-120-PTX (LOT #C775728). THE STENT WAS IMPLANTED IN THE PT THEREFORE, IS NOT AVAILABLE FOR EVAL. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE REQUESTED BUT WERE NOT AVAILABLE. IT MAY BE NOTED THAT RE-STENOSIS IS A COMMON ADVERSE EVENT OF ENDOVASCULAR PROCEDURES AND CAN BE CAUSED BY INJURY TO THE VESSEL (E.G. DURING PTA AND/OR STENTING). VESSEL INJURY PROVOKES AN INFLAMMATORY RESPONSE THAT LEADS (OR AMPLIFIES) TO THE RESTENOSIS PROCESS. IT IS VERY UNLIKELY THAT RESTENOSIS COULD HAVE OCCURRED DUE TO ZILVER PTX MALFUNCTION. HOWEVER, A DEFINITIVE ROOT CAUSE OF THIS STENT RE-STENOSIS CANNOT BE DETERMINED. AS PER INSTRUCTIONS FOR USE, RESTENOSIS OF THE STENTED ARTERY IS NOTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PLACEMENT OF THIS DEVICE. A REVIEW OF THE RELEVANT MFG RECORDS FOR ZILVER PTX AND ZILVER PTX DRUG ELUTING STENT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. SINCE THERE ARE NO IMAGES AVAILABLE FOR REVIEW, THERE IS NO EVIDENCE TO SUGGEST THAT RE-STENOSIS DID NOT OCCUR; THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER THE INFO PROVIDED PTA WAS CONDUCTED AND THE PT RECOVERED THE NEXT DAY. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE COMPLAINT DEVICE WAS PLACED IN RIGHT LOWER SFA. ON (B)(6) 2013, STENOSIS OR OCCLUSION OF NON-STUDY LESION (PROXIMAL TO THE LESION AND LEFT LOWER LIMB) WAS CONFIRMED AND TREATED. THE PT RECOVERED THE NEXT DAY. ON (B)(6) 2013, STENOSIS OR OCCLUSION OF NON-STUDY LESION (DISTAL TO THE LESION) WAS CONFIRMED AND TREATED. THE PT RECOVERED THE NEXT DAY. ON THE (B)(6) 2014, REOCCLUSION OF THE LESION (ZILVER PTX +/- 5MM, NOT THROMBOSIS) WAS CONFIRMED. REST PAIN AND NUMBNESS WERE OBSERVED TO THE PT. PTA WAS CONDUCTED ON THE SAME DAY AND THE PT RECOVERED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356739 ZILVER PTX DRUG - ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C775728

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention