BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 10377874 · Received August 7, 2020

    Report

    Report Number
    3001845648-2020-00482
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    December 5, 2019
    Report Date
    November 12, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. THE ZILVER 635 SELF-EXPANDING VASCULAR STENT DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. PRIOR TO DISTRIBUTION ZIV 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 COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. "THIS PRODUCT IS INTENDED FOR USE IN THE ILIAC ARTERIES." OFF-LABEL USE: USED IN THE HEPATIC ARTERY. A DEFINITIVE ROOT CAUSE IS OFF LABEL USE. THE DEVICE WAS USED IN THE HEPATIC ARTERY. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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

    THIS SUPPLEMENT FOLLOW-UP REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. KANG ET AL 2019 (ZIV6) ¿ ¿MID- TO LONG-TERM OUTCOMES IN MANAGEMENT OF SPONTANEOUS ISOLATED COELIAC ARTERY DISSECTION (SICAD)¿ ENDOVASCULAR INTERVENTION WAS PERFORMED THROUGH THE RIGHT COM-MON FEMORAL ARTERY APPROACH (EXCEPT IN ONE PATIENT IN WHOM THE BRACHIAL APPROACH WAS USED), AND SELF EXPAND-ABLE STENTS WERE PLACED. ONCE THE TRUE LUMEN WAS IDENTIFIED, STENTS WERE SIZED TO THE NORMAL DIAMETER OF THE PROXIMAL ARTERY AND PLACED AT THE ORIFICE OF THE COELIAC TRUNK. BOTH THE ENTRY SITE AND THE ENTIRE DISSECTION SEGMENT WERE COVERED USING SELF EXPAND-ABLE STENTS. THIS FILE HAS BEEN OPENED TO CAPTURE OFF LABEL USE IN THE COMMON HEPATIC ARTERY.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    KANG ET AL 2019 (ZIV6) ¿ ¿MID- TO LONG-TERM OUTCOMES IN MANAGEMENT OF SPONTANEOUS ISOLATED COELIAC ARTERY DISSECTION (SICAD).¿ ENDOVAS-CULAR INTERVENTION WAS PERFORMED THROUGH THE RIGHT COM-MON FEMORAL ARTERY APPROACH (EXCEPT IN ONE PATIENT IN WHOM THE BRACHIAL APPROACH WAS USED), AND SELF EXPAND-ABLE STENTS WERE PLACED. ONCE THE TRUE LUMEN WAS IDENTIFIED, STENTS WERE SIZED TO THE NORMAL DIAMETER OF THE PROXIMAL ARTERY AND PLACED AT THE ORIFICE OF THE COELIAC TRUNK. BOTH THE ENTRY SITE AND THE ENTIRE DISSECTION SEGMENT WERE COVERED USING SELF EXPAND-ABLE STENTS. THIS FILE HAS BEEN OPENED TO CAPTURE OFF LABEL USE IN THE COMMON HEPATIC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842762 ZILVER 635 VASCULAR SELF-EXPANDING STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR