BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1011466 · Received March 11, 2008

    Report

    Report Number
    1016427-2008-00061
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 16, 2008
    Report Date
    March 3, 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 EVALUATION AND TESTING. ADD'L INFO TO BE SUBMITTED 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS PRODUCT REPRESENTS ONE OF TWO CORDIS PRODUCTS THAT WERE USED IN THE SAME PROCEDURE AND IS RELATED TO MFG# 9616099-2008-00582 AND 1016427-2008-00061.

    Description of Event or Problem · 1

    AFTER POST DILATATION OF A STENT THAT WAS PLACED IN THE CAROTID ARTERY (SIDE UNK), BLOOD FLOW SLOWED. THE PHYSICIAN SUCTIONED THE DEBRIS FROM THE FILTER BASKET BY USING A SUCTION CATHETER, THEN, THE CAPTURE SHEATH WAS DELIVERED AND THE ANGIOGUARD FILTER WAS WITHDRAWN WITHOUT ANY DIFFICULTY. THERE WAS NO NEUROLOGICAL SYMPTOM DURING THE PROCEDURE. HOWEVER, THE PT DEVELOPED PARALYSIS ON RIGHT UPPER LIMB AFTER THE PROCEDURE. THE PT IS A MALE. THE CAROTID ARTERY STENTING PROCEDURE TOOK PLACE IN 2008. THERE IS NO INFO REGARDING THE TARGET CHARACTERISTICS. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS IN PLACE DISTAL TO THE LESION. THE TARGET LESION WAS PRE-DILATED WITH AN AMIIA BALLOON. A PRECISE STENT WAS PLACED, AND POST DILATED WITH ANOTHER AMIIA BALLOON. THERE WAS NO DIFFICULTY PLACING THE STENT IN THE LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO NEUROLOGICAL SYMPTOMS NOTED DURING THE PROCEDURE. HOWEVER, THE PT DEVELOPED PARALYSIS OF RIGHT UPPER LIMB SOMETIME AFTER THE PROCEDURE (EXACT DATE OF THE EVENT IS UNK). THE PARALYSIS SLIGHTLY REMAINS, AND THE PT IS IN STABLE CONDITION. THE PHYSICIAN DOES NOT THINK THE EVENT WAS CAUSED BY ANY OF THE CORDIS PRODUCTS.

    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 71206512

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R TWO AMIIA BALLOONS (CAT & LOT UNK)