BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1021166 · Received March 27, 2008

    Report

    Report Number
    1016427-2008-00090
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Removal / Correction Number
    NA
    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 AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT# 1016427-2008-00090 AND 9616099-2008-00802.

    Description of Event or Problem · 1

    AFTER POST-DILATATION OF A CAROTID STENT, BRADYCARDIA APPEARED. THERE WAS ALSO SLIGHT LALOPATHY AND PARALYSIS OF THE LEFT HAND. AN MRI OF THE BRAIN WAS PERFORMED AND REVEALED AN INFARCT. THE PT'S BLOOD PRESSURE WAS ALSO UNSTABLE. THE PHYSICIAN BELIEVES THAT CAUSE OF THE INFARCT WAS PLAQUE PASSING THROUGH THE FILTER BASKET. THE PT WAS A MALE. THE TARGET LESION WAS THE CAROTID ARTERY (NO FURTHER INFO PROVIDED). THERE WAS NO CALCIFICATION OR VESSEL TORTUOSITY, 90% STENOSIS. THE ANGIOGUARD WAS DELIVERED AND THE FILTER WAS DEPLOYED DISTAL TO THE LESION. THERE WAS GOOD WALL APPOSITION WITH THE FILTER BASKET AND THE WALL OF THE VESSEL. THE LESION WAS PRE-DILATED WITH A 3X20MM GATEWAY BALLOON (BOSTON SCIENTIFIC), A PRECISE STENT (8MMX40MM) IMPLANT, AND POST-DILATED WITH A 5MMX20MM BALLOON (BRAND UNK). AFTER POST-DILATATION, BRADYCARDIA APPEARED. AN ANTICOAGULATION MEDICATION WAS ADMINISTERED. THERE WAS ALSO SLIGHT LALOPATHY AND PARALYSIS OF THE LEFT HAND. THE LESION WAS SUCCESSFULLY TREATED. AFTER THIRTY MINS, LALOPATHY WAS IMPROVED AND THE PT'S LEFT HAND BECAME MOVABLE. AN MRI OF THE BRAIN WAS PERFORMED AND REVEALED AN INFARCT. THE NEXT DAY, HEADACHE AND HEMIPLEGIA ON LEFT SIDED APPEARED. THE PT'S BLOOD PRESSURE WAS ALSO UNSTABLE. TREATMENT IS UNK. THE PT IS IN STABLE CONDITION.

    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 71206502

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R (BOSTON SCIENTIFIC| (BRAND UNK)| 3X20MM GATEWAY BALLOON