BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1202192 · Received October 16, 2008

    Report

    Report Number
    1016427-2008-00269
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STUDY, PT UNDERWENT CAROTID STENT IMPLANTATION AND DURING THE PROCEDURE, THE ANGIOGUARD DEVICE FRACTURED/SEPARATED PRIOR TO USE. THE PT IS A FEMALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, CLINICAL COPD, CARDIAC ARRHYTHMIA, CONGESTIVE HEART FAILURE, AND HYPERTENSION. THE PT MEETS THE HIGH-RISK CRITERIA OF GREATER THAN 75 YEARS OF AGE AND SEVERE LEFT VENTRICULAR DYSFUNCTION WITH LVEF <35%. WHEN THE PHYSICIAN REMOVED THE ANGIOGUARD FROM THE STERILE PACKAGE AND BEGAN PREPARATION, HE NOTED THE WIRE WAS SEPARATED FROM THE LUMEN. THE ANGIOGUARD WAS NOT USED IN THE PT AND A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY FOR THE PT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 70108511 WAS PERFORMED; THIS PACKAGING LOT CONTAINED A TOTAL UNITS, WHICH WERE SHIPPED ON FEBRUARY 7, 2008. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT OF DEVICE FRACTURE/SEPARATION COULD NOT BE CONFIRMED WITHOUT THE PRODUCT FOR ANALYSIS. REVIEW OF THE INFO DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT WHILE PREPPING THE 6MM ANGIOGUARD, THE PHYSICIAN FOUND THE WIRE WAS SEPARATED FROM LUMEN. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE FILTER AND ANOTHER 6MM ANGIOGUARD WAS USED FOR THE PROCEDURE; THE PROCEDURE WAS COMPLETED BY SUCCESSFUL PLACEMENT OF AN 8X30MM PRECISE STENT. THERE WAS NO INJURY OR ADVERSE EVENTS REPORTED FOR THE PT. FURTHER INFO INDICATED THAT THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID. PRIOR TO THE REVASCULARIZATION PROCEDURE, ANGIOGRAPHY WAS CONDUCTED REVEALING 88% STENOSIS. DURING THE INDEX PROCEDURE, THE PT WAS ASYMPTOMATIC. THE LESION WAS 22 MM LONG AND PRESENTED A 6.0 MM REFERENCE VESSEL DIAMETER; ARCH TYPE I WITHOUT GREAT VESSEL VARIANT. THE LESION WAS ECCENTRIC, PRESENTING MODERATE AND CONCENTRIC CALCIFICATION AND NO VESSEL TORTUOUSITY. POST-STENTING, THE TARGET LESION PRESENTED A 7% DIAMETER STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70108511

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR CLOPIDOGREL| PATIENT'S MEDICATION INCLUDED: HEPARIN| ASPIRIN