BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3181586 · Received June 21, 2013

    Report

    Report Number
    1016427-2013-00084
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) REGISTRY DURING THE INDEX PROCEDURE THE OPERATOR EXPERIENCED RETRIEVAL DIFFICULTY WITH THE ANGIOGUARD WHICH REQUIRED ADVANCING A SHUTTLE SHEATH THROUGH THE STENT TO RETRIEVE THE FILTER. CAROTID ARTERY STENTING WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. A 6MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION, IT WAS PRE-DILATED AND A 10X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED. THE FILTER WAS SUCCESSFULLY REMOVED. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THERE WAS NO DOCUMENTED PRESENCE OF AIR BUBBLES OR DISSECTION. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS. LAKE REGION LOT NUMBER 10212503 IS CORDIS LOT NUMBER 71212430. PER LAKE REGION REPORT C (B)(4). LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10212503. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS, DEVICE INTERACTION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE SAPPHIRE REGISTRY DURING THE INDEX PROCEDURE THE OPERATOR EXPERIENCED RETRIEVAL DIFFICULTY WITH THE ANGIOGUARD IT REQUIRED ADVANCING A SHUTTLE SHEATH THROUGH THE STENT TO RETRIEVE THE FILTER. CAS WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY OF 6MM IN A 5.0MM VESSEL DIAMETER. THE LESION WAS CHARACTERIZED WITH AN ARCH I LESION. A 6MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION, IT WAS PRE-DILATED AND A 10X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE FILTER WAS SUCCESSFULLY REMOVED. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THERE WAS NO DOCUMENTED PRESENCE OF AIR BUBBLES OR DISSECTION. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281991 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71212430

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR PRECISE PRO RX STENT PC1040RXC