BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1023323 · Received April 1, 2008

    Report

    Report Number
    1016427-2008-00095
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 15, 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

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE US; HOWEVER, IT IS SIMILAR TO THE US PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AFTER THE POST-DILATATION OF TWO CAROTID STENTS, THE BLOOD FLOW STOPPED IN THE VESSEL. THEREFORE, THE PHYSICIAN SUCTIONED THE DEBRIS BY A SUCTION CATHETER (ELIMINATE). THE PT BECAME SYMPTOMATIC, SO THE PHYSICIAN ANTICOAGULATED THE PT AFTER THE POST-DILATATION, BUT THE PT DEVELOPED A STROKE. THE PT IS A MALE. THE TARGET LESION WAS INTERNAL CAROTID ARTERY (NO FURTHER DETAIL IS PROVIDED). THERE IS NO INFO ABOUT THE TARGET CHARACTERISTICS. THEY APPROACHED THE LESION FROM THE FEMORAL ARTERY. THE ANGIOGUARD WAS DELIVERED TO THE DISTAL OF THE TARGET. PRE-DILATATION WAS CARRIED OUT WITH AN AMIIA (CAT/LOT UNK) BALLOON. THE PHYSICIAN THEN DEPLOYED TWO PRECISE STENTS AT THE LESION. POST-DILATATION WAS CARRIED OUT WITH ANOTHER AMIIA (CAT/LOT UNK) BALLOON. AFTER THE POST-DILATATION, BLOOD FLOW STOPPED. THEREFORE, THE PHYSICIAN SUCTIONED THE DEBRIS FROM THE FILTER BASKET BY USING A SUCTION CATHETER (ELIMINATE). THERE IS NO INFO AS TO WHAT MEDICATIONS WERE GIVEN FOR ANTICOAGULATION. THERE IS NO INFO REGARDING THE RESIDUAL EFFECTS OF THE STROKE. ALSO, THERE IS NO INFO REGARDING THE PT'S MEDICAL HISTORY OTHER THAN HE HAS SYMPTOMS OF STROKE. THE PHYSICIAN DOES NOT BELIEVE THAT ANY OF THE CORDIS PRODUCTS CAUSED THE EVENT.

    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 71107504

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R TWO AMIIA BALLOONS (CAT & LOT # UNK)