BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 2212520 · Received August 16, 2011

    Report

    Report Number
    1016427-2011-00077
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01429538. THIS PACKAGING LOT CONTAINED 75 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JANUARY 14, 2011. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS CAUSED BY DEVICE INTERACTION AND DEVICE MOVEMENT CAUSED BY THE PATIENTS MOVEMENT AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(4) STUDY. THE PATIENT WAS A MALE WITH A HISTORY OF HYPERLIPIDEMIA, COPD, CORONARY ARTERY DISEASE, UNSTABLE ANGINA, AND HYPERTENSION. THE TARGET LESION WAS THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. PRE-PROCEDURE STENOSIS WAS 90%. LESION LENGTH WAS 10MM AND VESSEL DIAMETER WAS 5MM. THE VESSEL WAS SEVERELY CALCIFIED AND TORTUOUS. AN ANGIOGUARD RX, SIZE 5 WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN HAD DIFFICULTY REMOVING THE ANGIOGUARD GUIDEWIRE. DEFECT OCCURRED DURING RETRIEVAL INTO THE CAPTURE SHEATH. A PRECISE PRO RX 9 X 30MM STENT WAS DEPLOYED AT THE TARGET LESION. THE PATIENT WAS DISCHARGED 2 DAYS POST-PROCEDURE. ADDITIONAL INFORMATION RECEIVED: AFTER PLACEMENT OF THE STENT, THERE WAS EVIDENCE OF SOME SPASM AT THE FILTER SITE THAT HAD ACTUALLY MIGRATED MORE PROXIMAL. THE FILTER WAS THEN RETRIEVED WITH SIGNIFICANT DIFFICULTY SECONDARY TO IT BECOMING ADHERED TO THE STENT ITSELF. THIS WAS ASSOCIATED WITH THE PATIENT'S MOVEMENT AND SLIPPAGE OF THE MAIN SHEATH DOWN THE COMMON CAROTID ARTERY, THUS PULLING THE FILTER ALONG WITH IT. HOWEVER, ESSENTIALLY THE FILTER WAS CLEARLY ENGAGED ONTO THE STENT AND THIS COULD NOT BE REMOVED WITHOUT PASSING THE SHEATH BACK INTO POSITION, THROUGH THE STENT, TO PEEL THIS OFF THE STENT. REVIEW OF THE FILTER SHOWED THIS TO BE POSITIVE FOR DEBRIS AND ALSO ONE THIRD OF THE EMBOLIC SHIELD WAS PULLED FREE FROM ITS ATTACHMENT SITE. THE ENTIRE NETTING APPEARED TO BE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71210512

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR MEDICATIONS: HEPARIN