BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3170282 · Received June 14, 2013

    Report

    Report Number
    1016427-2013-00077
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    March 5, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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

    AFTER DEPLOYMENT OF THE ANGIOGUARD IN THE DISTAL RIGHT CERVICAL INTERNAL CAROTID ARTERY ANGIOPLASTY WAS PERFORMED WITH A STERLING 3.5-MM BALLOON FOLLOWED BY DEPLOYMENT OF A 6 X 20 MM STENT. POST STENTING ANGIOPLASTY WAS PERFORMED WITH A 5MM STERLING BALLOON. ATTEMPTED RETRIEVAL OF THE ANGIOGUARD DISTAL PROTECTION DEVICE WAS UNSUCCESSFUL WITH THE SUPPLIED CAPTURE SHEATH, THEREFORE A NON CORDIS RETRIEVAL DEVICE WAS PASSED ACROSS THE STENT AND THE DISTAL PROTECTION DEVICE WAS RETRIEVED WITHOUT DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY. CAROTID ARTERY STENTING WAS BEING PERFORMED ON AN 85% OCCLUDED LESION IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY OF 5MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH I LESION WAS ECCENTRIC, ULCERATED AND SEVERELY CALCIFIED. LR PACKAGING L/N # 10071398, 71111462. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10071398. (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 (B)(6) STUDY INDICATED THAT DURING INDEX PROCEDURE THE ANGIOGUARD FAILED TO RETRIEVE INTO THE CAPTURE SHEATH. IT WAS REMOVED AND ANOTHER DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY. CAROTID ARTERY STENTING WAS BEING PERFORMED ON AN 85% OCCLUDED LESION IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY OF 5MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH I LESION WAS ECCENTRIC, ULCERATED AND SEVERELY CALCIFIED. A 5MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED PAST THE LESION WHICH WAS THEN PRE-DILATED BUT A STENT WAS NOT DEPLOYED. THE RESIDUAL DIAMETER STENOSIS WAS 0%. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES. 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
    270879 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71111462

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ABBOTT EMBOLIC PROTECTION DEVICE