BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1800908 · Received August 10, 2010

    Report

    Report Number
    3004742046-2010-00354
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 21, 2010
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRADYCARDIA AND HYPOTENSION MAY OCCUR DURING THIS TYPE OF PROCEDURE, AS LISTED IN THE INSTRUCTIONS FOR USE, AND ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE PRODUCT. HYPOTENSION AND BRADYCARDIA MAY OCCUR DURING CAROTID INTERVENTIONAL PROCEDURES AND IT IS ANTICIPATED RESPONSE OF THE HUMAN BODY TO STIMULUS OF THE CAROTID BULB. THERE WAS NO DEVICE MALFUNCTION REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. BASED ON AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT ADVERSE EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, HOWEVER, THERE WAS NO INDICATION OF ANY PRODUCT DEFICIENCIES WHICH COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PROCEDURE.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): HYPOTENSION. ONSET OF AE: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL, THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER POST-STENT DILATATION WITH A NON-ABBOTT DILATATION BALLOON, THE PATIENT BECAME BRADYCARDIC AND WAS TREATED WITH ATROPINE. POST-PROCEDURE, THE BRADYCARDIA RESOLVED, BUT THE PATIENT EXPERIENCED HYPOTENSION AND WAS STARTED ON AN INTRAVENOUS NEOSYNEPHRINE DRIP. THE BLOOD PRESSURE REMAINED LABILE. ON (B)(6) 2010, THE BLOOD PRESSURE STABILIZED AND THE PATIENT WAS ABLE TO BE WEANED FROM THE NEOSYNEPHRINE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9112451

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R EMBOLIC PROTECTION: RX ACCUNET| 1011649-65, LOT # 0012751| BIVALIRUDIN| DIL CATH: VOYAGER DILATATION BALLOON 3.5 X 30 MM| CORDIS AVIATOR DILATATION BALLOON 6 X 20 MM