BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1020270 · Received March 25, 2008

    Report

    Report Number
    3004742046-2008-00067
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT: THE STENT DELIVERY SYSTEM WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION WITH TRANSIENT ISCHEMIC SYMPTOMS. TIME OF AE: DURING AND POST PROCEDURE. IT WAS REPORTED THAT DURING A POST RIGHT INTERNAL CAROTID ARTERY STENT DEPLOYMENT, THE PATIENT EXPERIENCED HYPOTENSION WITH EPISODES OF TRANSIENT ISCHEMIC ATTACK WITH LEFT-SIDED WEAKNESS, GARBLED SPEECH AND DIZZINESS WHICH WERE SIMILAR TO HER SYMPTOMS PRE-PROCEDURE AND WHICH WERE DEPENDENT ON HER BLOOD PRESSURE AND POSITION. SHE WAS TREATED WITH FLUIDS, ATROPINE, DOPAMINE, PHENYLEPHRINE AND PACKED RED BLOOD CELLS FOR ANEMIA, WHICH ALONG WITH CONGESTIVE HEART FAILURE PROLONGED HOSPITALIZATION. THE SYMPTOMATIC HYPOTENSION RESOLVED WITHOUT RESIDUAL DEFICITS AND THE PATIENT WAS DISCHARGED TO HOME IN 08. AT THE TIME OF DISCHARGE, HER ANTIHYPERTENSIVE MEDICATIONS WERE REDUCED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 6082151

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HEPARIN| RX ACCUNET