BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1064735 · Received June 23, 2008

    Report

    Report Number
    3004742046-2008-00145
    Event Type
    Injury
    Date Received
    June 23, 2008
    Date of Event
    July 1, 2007
    Report Date
    January 3, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: BEATRIZ ALVAREZ, MD, ET AL; "TRANSCERVICAL CAROTID STENTING WITH FLOW REVERSAL PROTECTION; EXPERIENCE IN HIGH-RISK PATIENTS." J VASC SURG 2007; 46:49-54. EVAL SUMMARY: THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. NO DEVICES WERE AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBERS WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. TIA, STROKE, HEMORRHAGE, RESTENOSIS, BRADYCARDIA, HYPOTENSION, SPASM, AND DISSECTION ARE REFERENCED AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH THE USE OF STENTS IN THE DEVICE INSTRUCTIONS FOR USE (IFU). FURTHERMORE, NO DEVICE MALFUNCTIONS WERE DESCRIBED. THESE EVENTS DO NOT APPEAR TO BE RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: BRADYCARDIA, SPASM, TIA'S, STROKE, CEREBRAL HEMORRHAGE, HYPOTENSION, DISSECTION AND RESTENOSIS. TIME OF SYMPTOMS: DURING AND AFTER THE PROCEDURE. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED OF 62 TRANSCERVICAL CAROTID ARTERY STENTING IMPLANTED IN HIGH RISK PTS. NINE PTS WERE TREATED WITH ATROPINE FOR TRANSIENT BRADYCARDIA. TWO PTS HAD SIGNIFICANT DISTAL INTERNAL CAROTID SPASM TREATED WITH INTRA-ARTERIAL NITROGLYCERIN. ONE PT HAD A TIA OF THE ANTERIOR CEREBRAL ARTERY THAT RECOVERED WITHIN 12 HOURS. ONE PT EXPERIENCED A STROKE WITH CONTRALATERAL HEMIPLEGIA; DOPPLER US SHOWED AN IN-STENT THROMBOSIS AND A CT SAN SHOWED ACUTE INFARCTION SIGNS IN THE MCA TERRITORY IPSILATERAL TO THE TARGET LESION. AT 48 HOURS AFTER HOSPITAL DISCHARGE, THE PT RETURNED TO THE HOSPITAL WITH HEMIPLEGIA AND APHASIA AFTER AN EPISODE OF INTENSE HEADACHE; A CT SCAN SHOWED A SEVERE CEREBRAL HEMORRHAGE THT REQUIRED A SURGICAL DRAINAGE. ONE PT PRESENTED PERSISTENT HYPOTENSION DURING THE FIRST 12 HOURS AND REQUIRED NORADRENALINE INFUSION. ONE MAJOR DISSECTION WAS SEEN IN A PT AFTER STENT PLACEMENT AND A BYPASS PROCEDURE WAS PERFORMED WITH NO NEUROLOGICAL EFFECTS. THERE WERE TWO CASES OF SIGNIFICANT RESTENOSIS (50% TO 70%) AND ONE RESTENOSIS GREATER THAN 70%. THE ARTICLE DOES NOT CORRELATE THE PT OUTCOMES TO A SPECIFIC STENT MANUFACTURE AND NO DEVICE MALFUNCTIONS WERE DESCRIBED FOR THESE EVENTS. THE PROTECTION SYSTEM USED WAS CAROTID FLOW REVERSAL BY TRANSCERVICAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76.5 YR Hospitalization| R 4FR CATHETER| HEPARIN| GUIDE WIRE: 0.014 SPARTACORE| BOSTON SCI WALLSTENTS (29)| DIL CATH: ABBOTT VIATRAC PLUS| BOSTON ULTRA-SOFT ANGIOPLASTY BALLOON| BOSTON 0.014 PLATINUM PLUS| STENT: ABBOTT RX ACCULINK (33)