BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 18757643 · Received February 22, 2024

    Report

    Report Number
    3001845648-2024-00063
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    October 28, 2023
    Report Date
    July 29, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002352831
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S014. SUPPLEMENTAL REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. SEVERITY LEVEL WAS UPDATED TO 'SERIOUS INJURY'.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #P100022/S014 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P100022/S014. THIS FILE WAS OPENED TO CAPTURE A COMPLAINT OF SUSPECTED ALLERGIC REACTION, ¿THE PATIENT DEVELOPED A RASH ALL OVER THE BODY¿. 2 DIFFERENT STENTS WERE USED IN THE SAME PROCEDURE, AND BOTH ARE CAPTURED UNDER INDIVIDUAL PRS. THIS FILE IS RELATED TO (B)(4). DEVICE EVALUATION: ZISV6-35-125-6.0-80-PTX DEVICE OF LOT NUMBER C2032369 INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL: THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ¿THE JAPANESE PACKAGING INSERT (B)(4) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER, STATES THAT POTENTIAL ADVERSE EVENTS WHICH MAY OCCUR IN USE OF THIS DEVICE INCLUDE ALLERGIC REACTION TO ANTICOAGULANT, ANTIPLATELET AND/OR ANTITHROMBOTIC THERAPY OR CONTRAST MEDIUM, ALLERGIC REACTION TO NITINOL, HYPERSENSITIVITY REACTIONS AND ALLERGIC/IMMUNOLOGICAL REACTION TO THE DRUG COATING. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION PROVIDED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A POSSIBLE ALLERGIC REACTION TO NITINOL, WHICH IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE DEVICE PACKAGING INSERT. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO A POSSIBLE ALLERGIC REACTION TO NITINOL, WHICH IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE DEVICE PACKAGING INSERT. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. CORRECTIVE ACTION/ CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED TO CAPTURE A COMPLAINT OF SUSPECTED ALLERGIC REACTION, IT WAS REPORTED THAT ¿THE PATIENT DEVELOPED A RASH ALL OVER THE BODY¿. CONFIRMED QUANTITY OF (B)(4) DEVICE USED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RECOVERED AFTER RECEIVING STEROIDS. INVESTIGATION FINDINGS CONCLUDE A POSSIBLE ROOT CAUSE OF ALLERGIC REACTION TO NITINOL.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. SEVERITY LEVEL WAS UPDATED TO 'SERIOUS INJURY'.

    Description of Event or Problem · 0

    24OCT2023: ZISV6-35-125-6.0-80-PTX ((B)(4)) AND ZISV6-35-125-6.0-140-PTX ((B)(4)) WERE PLACED IN SFA. (B)(6) 2023: THE PATIENT DEVELOPED A RASH ALL OVER THE BODY. AN ALLERGY TO THE METALS USED IN ZILVER PTX OR TO PACLITAXEL WAS SUSPECTED. THE PATIENT WAS FOLLOWED UP. (B)(6) 2023: THE PATIENT RECOVERED. THE PATIENT RECOVERED ON (B)(6) 2023. USER¿S COMMENT: I SUSPECTED AN ALLERGY TO THE METALS USED IN ZILVER PTX OR TO PACLITAXEL. SALES REP'S COMMENT: SAME AS THE PHYSICIAN. [ADDITIONAL INFORMATION] 4-1 ARE IMAGES OF THE DEVICE OF PROCEDURE AVAILABLE? NO IMAGE AVAILABLE 4-2 WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? UNKNOWN 4-3 IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? UNKNOWN 4-4 WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES 4-5 WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? YES 4-6 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? UNKNOWN 4-7 DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? UNKNOWN 4-8 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU YES 4-9 WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA 4-10 WAS THE PATIENT'S ANATOMY TORTUOUS OR CALCIFIED? NO 4-11 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE OR DELIVERY SYSTEM TO THE TARGET LOCATION? NO 4-12 HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? 4-13 DID THE STENT DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 29-JUL-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48773 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD C2032369 10827002352831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention