BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 11775454 · Received May 5, 2021

    Report

    Report Number
    3001845648-2021-00366
    Event Type
    Injury
    Date Received
    May 5, 2021
    Report Date
    January 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL 510(K) NUMBER'S P100022/S026, P100022/S014, P100022/S027 OR P100022/S001. DEVICE EVALUATION THE ZISV6 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE "TOMOI 2015". THIS FILE WAS OPENED TO INVESTIGATE IN-STENT THROMBUS. LAB EVALUATION ¿ N/A. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZISV6 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. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0117-5) LIST ARTERIAL THROMBOSIS AS A POTENTIAL ADVERSE EVENT AND ALSO STATES THE FOLLOWING - NOTE: FLOW RESTRICTIONS REMAINING AFTER STENT DEPLOYMENT (E.G., RESIDUAL PROXIMAL OR DISTAL STENOSIS OR DISSECTION, OR POOR DISTAL OUTFLOW) MAY INCREASE THE RISK OF STENT THROMBOSIS. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE PATIENT¿S PRE-EXISTING CONDITION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENTS WERE TREATED FOR SUPERFICIAL FEMORAL ARTERY LESIONS AND ALL PATIENTS EXHIBITED INTERMITTENT CLAUDICATION (RUTHERFORD CATEGORY 3). IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS CAUSED AND/OR CONTRIBUTED TO THROMBUS FORMATION. AS MENTIONED ABOVE THROMBOSIS IS A KNOWN INHERENT RISK OF ENDOVASCULAR STENTING AND IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EVENT. HOWEVER, THERE IS NO EVIDENCE WITHIN THE JOURNAL ARTICLE TO SUGGEST ANY DEVICE MALFUNCTION OR DETERIORATION IN DEVICE CHARACTERISTICS. THEREFORE, IT IS MORE LIKELY THAT PATIENT PRE-EXISTING CONDITIONS CAUSED OR CONTRIBUTED TO THROMBUS FORMATION. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. FROM THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE PATIENT EXPERIENCED 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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    POTENTIAL 510(K) NUMBER'S: P100022/S026, P100022/S014, P100022/S027 OR P100022/S001. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    TOMOI, 2015, ZILVER PTX AND ¿VASCULAR RESPONSE AFTER ZILVER PTX STENT IMPLANTATION FOR SUPERFICIAL FEMORAL ARTERY LESIONS: SERIAL OPTICAL COHERENCE TOMOGRAPHY FINDINGS AT 6 AND 12 MONTHS.¿ PURPOSE:TO COMPARE THE VASCULAR RESPONSE AFTER PACLITAXEL-COATED NITINOL DRUG-ELUTING STENT (ZILVER PTX) IMPLANTATION FOR SUPERFICIAL FEMORAL ARTERY LESIONS AFTER 6 AND 12 MONTHS USING OPTICAL COHERENCE TOMOGRAPHY (OCT). SERIAL OCT EXAMINATIONS WERE PERFORMED IN 5 PATIENTS (4 MEN; MEAN AGE 78.4±6.8 YEARS) WITH 9 ZILVER PTX STENTS AT 6- AND 12-MONTH FOLLOW-UP. THE OCT EXAMINATION WAS PERFORMED WITH A FREQUENCY DOMAIN SYSTEM (C7-XR; ST. JUDE MEDICAL, ST. PAUL, MN, USA) USING A 4.5-F GUIDING CATHETER (PARENT PLUS 45; MEDIKIT, TOKYO, JAPAN) AS A SHEATH VIA THE BRACHIAL ARTERY APPROACH. THE STENT WAS IMAGED USING AN AUTOMATIC PULLBACK DEVICE THAT MOVED THE OCT CATHETER AT 20 MM/S; DIGITAL IMAGES WERE CAPTURED AT AN ACQUISITION RATE OF 100 FRAMES PER SECOND. IN-STENT THROMBUS WAS OBSERVED IN 10% AND 12% OF THE CROSS SECTIONS, AND THE MEDIAN THROMBUS AREA WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN 6 AND 12 MONTHS [0.04 (0.03¿0.09) VS. 0.06 (0.02¿0.17) MM2, P=0.13].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671810 ZILVER PTX 35 DRUG-ELUTING STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention