BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 760913 · Received September 11, 2006

    Report

    Report Number
    3004742046-2006-00385
    Event Type
    Injury
    Date Received
    September 11, 2006
    Date of Event
    August 8, 2006
    Report Date
    August 16, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND RX ACCULINK PART# 1011340-20/LOT# 6050851 IS INDICATED AND IS BEING FILED UNDER THE SAME MFR RPT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. ADVERSE EVENT: HYPOTENSION. TIME OF ADVERSE EVENT: DURING AND AFTER PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL STENT IMPLANTATION , IN 2006, OF TWO LESIONS, ONE IN THE RICA AND THE OTHER IN THE RCCA. AFTER THE SECOND STENT WAS DEPLOYED AND AFTER POST DILATATION, THE PATIENT EXPERIENCED HYPOTENSION WITH A BLOOD PRESSURE OF 79/46. THE PATIENT WAS TREATED WITH A NEOSYNPHRINE DRIP AND HIS BLOOD PRESSURE INCREASED TO 124/53. THE PATIENT ALSO COMPLAINED OF A SLIGHT HEADACHE THAT RESOLVED WITH ONE DOSE OF TYLENOL ON THE SAME DAY, AS WELL AS NAUSEA AND VOMITING DURING THE FIRST NIGHT POST-PROCEDURE AND TRANSIENT RIGHT MANDIBULAR PAIN. THE PATIENT WAS DISCHARGED TO HOME ON TWO DAYS LATER. HIS BLOOD PRESSURE AT THE TIME OF DISCHAGE WAS REPORTED AT 85/46. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 4113051

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization VIATRAC 14 PLUS 5X 20| DILATATION CATHETER: VIATRAC 14 PLUS 5X20X135| RX ACCUNET 5.5 PART# 1011649-55/LOT# 6021651| RX ACCULINK II 8/20 PART # 1011340-20/LOT# 6050851