BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1202194 · Received October 16, 2008

    Report

    Report Number
    1016427-2008-00268
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 24, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS COMPLETED IN 2008. THE ARCH TYPE WAS III AND NO THROMBUS WAS PRESENT AT THE TARGET SITE. NO REVASCULARIZATION WAS PLANNED. THE TARGET LESION LOCATION WAS LEFT EXTERNAL CAROTID ARTERY. THE LESION WAS MODERATELY CALCIFIED, SEVERELY TORTUOUS, AND ULCERATED/ECCENTRIC. THE TARGET LESION DIAMETER STENOSIS WAS 90% WITH A LENGTH OF 18.0, ANGIOGRAPHIC REFERENCE VESSEL DIAMETER 6.0, AND THE TOTAL LENGTH OF STENTED SEGMENT WAS 40.0. THE COMPLAINT ANGIOGUARD DEVICE WAS OPENED AND INSERTED, BUT DURING REMOVAL, THE REPORTED EVENT NOTED ABOVE OCCURRED. A NON-STUDY STENT (PROTEGE RX) WAS IMPLANTED AT THE SITE WITHOUT DIFFICULTIES. NO OCCLUSION WAS NOTED IN THE CONTRA LATERAL CAROTID WAS REPORTED. NO NEUROLOGICAL DEFICIT WAS NOTED WHEN THE PT WAS REMOVED FROM ANGIOGRAPHIC SUITE, AND THE PT DID NOT REQUIRE EMERGENT CAROTID SURGERY. NO OCCLUSION OR AIR BUBBLES WERE DOCUMENTED. AN (ECG) ELECTROCARDIOGRAM WAS OBTAINED AFTER THE PROCEDURE. THE CK WAS 80.0 (UPPER LIMIT WAS 240), AND THE CKMB WAS 1.8 (UPPER LIMIT WAS 5.0). AT THE TIME OF DISCHARGE, IT WAS NOTED THAT PRE PROCEDURE, THE PT RECEIVED ASPIRIN AND CLOPIDOGREL. DURING THE PROCEDURE, THE PT RECEIVED BIVALIRUDIN AND CLOPIDOGREL. AT THE TIME OF DISCHARGE, THE PT WAS ON ASPIRIN AND CLOPIDOGREL. TICLOPIDINE WAS ALSO CHECKED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PER STUDY INDICATED THAT THIS PT STROKE SCORE WAS 0 WITH NO HISTORY OF NEURO DEFICITS. THE MEDICAL HISTORY CONSISTED OF HYPERLIPIDEMIA, DIABETES MELLITUS, AND HYPERTENSION. ADDITIONALLY THE PT HAD HIGH-RISK CRITERIA CONSISTING OF CHF (CLASS III/IV) AND/OR KNOWN SEVERE LEFT VENTRICULAR DYSFUNCTION LVEF<35%, HIGH CERVICAL (ICA) INTERNAL CAROTID ARTERY LESIONS OR (CCA) COMMON CAROTID ARTERY LESIONS BELOW THE CLAVICLE AND AGE>75. THE REPORT INDICATED THAT THE ANGIOGUARD DEVICE WAS DIFFICULT TO REMOVE DUE RETRIEVAL DIFFICULTY WITH THE CAPTURE SHEATH. ADDITIONAL INFO WAS REQUESTED, BUT TO DATE, NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70807504

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR PROTEGE RX STENT