BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1545643 · Received November 24, 2009

    Report

    Report Number
    3004742046-2009-00326
    Event Type
    Injury
    Date Received
    November 24, 2009
    Date of Event
    November 5, 2009
    Report Date
    November 9, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K092286
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1: RX ACCULINK (PART# 1011344-40, LOT# 9092451) IS BEING FILED UNDER MEDWATCH MFR# 3004742046-2009-00325. THE DEVICE IS NOT AVAILABLE FOR EVAL. THE LOT # WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: NONE. SYMPTOMS/AE: EMBOLIZATION/INTERVENTION. TIME OF SYMPTOMS/AE: DURING PROCEDURE. IT WAS REPORTED THAT THE DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER POST-DILATATION OF THE RX ACCULINK STENT USING THE RX VIATRAC 14 PLUS DILATATION CATHETER, EMBOLI FROM A PRE-EXISTING THROMBUS CREATED SLOW FLOW. AN EMBOLECTOMY WAS PERFORMED USING A NON-ABBOTT ASPIRATION CATHETER AS WELL AS A MULTIPURPOSE CATHETER WITH SUCCESSFUL REMOVAL OF THE CLOT. AFTER REMOVAL OF THE EMBOLIC PROTECTION FILTER, A DISTAL VASOSPASM WAS NOTED. NITROGLYCERIN WAS ADMINISTERED AND THE VASOSPASM RESOLVED. INTRACRANIAL CIRCULATION REMAINED INTACT. THERE WAS NO ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention RX ACCUNET EMBOLIC PROTECTION DEVICE:| RX ACCULINK CAROTID STENT SYSTEM:| (PART# 1011344-40, LOT# 9092451)| BIVALIRUDIN| (PART# 1011649-65, LOT# 9052151)