BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR PTA DILATATION CATHETER

    MDR report key: 1051655 · Received May 21, 2008

    Report

    Report Number
    9610978-2008-00129
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 8, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DQY
    PMA / PMN Number
    K013581
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION TO BE SUBMITTED 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    FOLLOWING PRE-DILATION OF THE LESION A GRADE A DISSECTION WAS NOTED. THE PATIENT IS A MALE WHO WAS CONSENTED TO THE STUDY IN 2008. THE INDEX PROCEDURE WAS COMPLETED ON THE SAME DAY, AND PATIENT WAS SYMPTOMATIC. THE TARGET LESION LOCATION WAS THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. THERE WAS NO OCCLUSION IN THE CONTRALATERAL CAROTID. REFERENCE VESSEL DIAMETER WAS 5.5 MM. TARGET LESION DIAMETER STENOSIS WAS 85% WITH LESION LENGTH 24.0MM. TOTAL LENGTH OF STENTED SEGMENT WAS 30.0MM. QUALITATIVE LESION CALCIFICATION WAS DESCRIBED AS MODERATE AND CONCENTRIC. VESSEL TORTUOUSITY BY VISUAL INSPECTION WAS MILD. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED DISTAL TO THE LESION. PRE-DILATATION OF THE LESION WAS PERFORMED WITH AN AVIATOR BALLOON. THE LESION WAS RESISTANT TO ANGIOPLASTY. AFTER THE LESION WAS PRE-DILATED, IT WAS NOTED THAT A GRADE A DISSECTION HAD OCCURRED. A PRECISE STENT WAS IMPLANTED FOR TREATMENT OF TARGET LESION AND TO STABILIZE THE DISSECTION. THERE WAS NO MALFUNCTION WITH THE STENT. THE PATIENT WAS NEUROLOGICALLY INTACT WHEN TAKEN FROM THE ANGIO SUITE. ON THE SAME DAY, AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED LEFT SIDED VISUAL FIELD LOSS, HEMIPARESIS ON THE RIGHT SIDE AND BEHAVIORAL CHANGE. THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). THE ONSET WAS SUDDEN. THE SYMPTOMS OF THE TIA RESOLVED ON THEIR OWN WITHIN TWENTY-FOUR HOURS. THE PATIENT WAS DISCHARGED THREE DAYS LATER, WITH CLOPIDOGREL DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PTA DILATATION CATHETER PTA CATHETERS (DQY) (LIT) DQY CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R ANGIOGUARD DISTAL PROTECTION DEVICE