BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 3233984 · Received July 16, 2013

    Report

    Report Number
    3001845648-2013-00063
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    PMA / PMN Number
    P050017/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PMA/510(K) = P050017/S002 AND S003. THERE WAS NO ZFV6-35-6-60 DEVICE OF LOT C773049 IN STOCK AT THE TIME OF THE INVESTIGATION. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED AS IT WAS IMPLANTED IN THE PATIENT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IMAGES WERE AVAILABLE AND REVIEWED. BASED ON THE IMAGING REVIEW PROVIDED FOR THIS COMPLAINT, OCCLUSION COULD BE CONFIRMED. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE RE-OCCLUSION BASED UPON THE SUBMITTED IMAGING. PATIENT'S PRE-EXISTING CONDITIONS SUCH AS HYPERTENSION, DIABETES AND HYPERCHOLESTEROLEMIA COULD HAVE CONTRIBUTED TO THIS EVENT. ALSO ANATOMICAL FACTORS SUCH AS A PREVIOUS STENT PLACEMENT COULD HAVE CONTRIBUTED TO THIS EVENT. ZILVER FLEX DEVICE OF LOT C773049 CONTAINS RMN12-346 (ZVS-1.6-6-60-FLEX-GR(295173) OF LOTS QC119533, QC119534 AND QC119536. THESE STENTS ARE THE COMPONENTS INVOLVED IN THIS COMPLAINT AND UNDERGOES IQC. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILVER FLEX OF LOT C773049 AND ZVS-1.6-6-60-FLEX-GR (LOT NUMBERS QC119533, QC119534 AND QC119536) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ZILVER FLEX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. IT MAY BE NOTED THAT EMBOLISM IS A KNOWN POTENTIAL ADVERSE EFFECT AS PER INSTRUCTION FOR USE, IFU. THE OVERALL RISK ASSOCIATED WITH THIS OCCURRENCE HAS BEEN DETERMINED TO BE MODERATE. A TWO YEAR REVIEW OF THE 2 YEAR COMPLAINT HISTORY FOR ZFV6-35-80-6-60 DEVICES REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS RPN. THIS THEREFORE REPRESENTS AN ISOLATED OCCURRENCE OF THIS RPN OVER THIS TIMEFRAME. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6) 2013: A ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT (6MM X 60MM) WAS PLACED AT THE LESION (4CM) IN THE RIGHT SFA. (B)(6) 2013: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ASPIRIN AND TICLOPIDINE WERE ADMINISTERED. (B)(6) 2013: INTERMITTENT CLAUDICATION HAD BEEN WORSENED AND OCCLUSION BY THROMBOSIS AT PLUS OR MINUS 5MM OF THE ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT WAS CONFIRMED. (B)(6) 2013: BYPASS SURGERY WAS PERFORMED. THE PHYSICIAN REPORTED TO US THAT IT BECAME IMPOSSIBLE TO FOLLOW THE PATIENT (LOST-TO-FOLLOW-UP) AFTER THIS SURGERY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2013: THE PATIENT DEVELOPED CELLULITIS DUE TO BYPASS SURGERY BUT RECOVERED AFTERWARDS. THE PATIENT'S CONDITION IS UNKNOWN BECAUSE THIS CASE BECAME LOST-TO-FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328127 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO COOK IRELAND LTD C773049

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention