BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1171200 · Received September 22, 2008

    Report

    Report Number
    1016427-2008-00246
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT# 70608503. THIS PACKAGING LOT CONTAINED 128 UNITS, WHICH WERE SHIPPED IN 2008. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBERS: 1016427-2008-00246 AND 9616099-2008-02294. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, THE 6MM ANGIOGUARD WAS DELIVERED WITHOUT DIFFICULTIES. THE TARGET LESION WAS PRE-DILATED TO 10 ATMOSPHERES (ATMS) AND WAS SUBSEQUENTLY STENTED WITH A 10X40MM PRECISE STENT, THE LESION WAS POST-DILATED TO 8 ATMS. AFTER POST-DILATION, THE BLOOD FLOW STOPPED. THEREFORE, THE PHYSICIAN SUCTIONED THE BLOOD THREE TIMES AND THEN THE BLOOD FLOW WAS RECOVERED. THE ANGIOGUARD WAS RETRIEVED WITH THE CAPTURE SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT OTHER PROBLEMS. HOWEVER, THE PT EXPERIENCED MILD PARALYSIS ON HIS LEFT AND CEREBRAL INFARCTION WAS CONFIRMED BY MRI. THE PT IS UNDER TREATMENT CONSERVATIVELY. THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY PRESENTING MILD CALCIFICATION AND TORTUOUSITY WITH A 90% RATE OF STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70608503

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization BALLOON CATHETER AMIIA (4MM X 40MM)| SHUTTLE SHEATH (COOK)| STERING (4.5MM X 30MM/BOSTON SCIENTIFIC)