BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1545644 · Received November 24, 2009

    Report

    Report Number
    3004742046-2009-00325
    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
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. DEVICE #2: RX VIATRAC 14 PLUS DILATATION CATHETER (PART# 1008195-30, LOT# UNK) REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVAL SUMMARY: THE STENT REMAINS IN THE PT. VASOSPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE AS INDICATED IN THE RX ACCULINK INSTRUCTIONS FOR USE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: NONE. SYMPTOMS/AE: VASOSPASM. TIME OF SYMPTOMS/AE: POST 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 ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9092451

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention (PART# 1008195-30, LOT# UNK)| BIVALIRUDIN| (PART # 1011649-65, LOT# 9052151)| RX VIATRAC 14 PLUS DILATATION CATHETER:| RX ACCUNET EMBOLIC PROTECTION DEVICE: