BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 3120724 · Received May 20, 2013

    Report

    Report Number
    1016427-2013-00068
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    May 2, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE THE ANGIOGUARD FAILED TO RETRIEVE INTO THE CAPTURE SHEATH. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(4) STUDY FOR STENTING OF THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED AND MODERATELY TORTUOUS WITH A 90% STENOSIS. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED FOLLOWED BY SUCCESSFUL DEPLOYMENT OF A PRECISE STENT. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE ANGIOGUARD FILTER FROM THE VESSEL THERE WAS DIFFICULTY. THE PHYSICIAN WAS EVENTUALLY ABLE TO RETRIEVE THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. 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 AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE SAPPHIRE STUDY INDICATED THAT DURING INDEX PROCEDURE THE ANGIOGUARD FAILED TO RETRIEVE INTO THE CAPTURE SHEATH. THE PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED AND MODERATELY TORTUOUS. THE RATE OF STENOSIS WAS 90%. AN ANGIOGUARD (601814RMC/ LOT 71211512) EMBOLIC PROTECTION DEVICE WAS DEPLOYED DISTAL TO THE LESION AND THE LESION WAS PRE-DILATED. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE PROCEDURE WAS COMPLETED. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE ANGIOGUARD FILTER FROM THE VESSEL THERE WAS DIFFICULTY. THE PHYSICIAN WAS EVENTUALLY ABLE TO RETRIEVE THE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222446 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 71211512

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR PRECISE STENT