BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1972895 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00508
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. CEREBROVASCULAR ACCIDENT AND MI ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS KNOWN POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19, LOT # 0043051). OTHER: BIVALIRUDIN. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS REPORTED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT HOURS AFTER THE IMPLANTATION OF THE RX ACCULINK STENT IN THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A STROKE WITH LEFT SIDED WEAKNESS AND CONFUSION. THE CT SCAN OF THE HEAD SHOWS RIGHT THALAMIC HYPODENSITY OF INDETERMINATE AGE SUGGESTIVE OF INFARCT. THE MRI OF THE HEAD SHOWED MULTIPLE SCATTERED INFARCT OF INDETERMINATE AGE. THERE WAS NO REPORTED INTERVENTION. THE PATIENT'S STROKE SYMPTOMS RESOLVED THREE DAYS LATER. THE PATIENT HAD A MYOCARDIAL INFARCTION (MI) FOUR DAYS AFTER THE PROCEDURE THAT WAS TREATED WITH NITROGLYCERIN, HEPARIN, AND MORPHINE. THE PATIENT'S MI RESOLVED THE SAME DAY. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD A SECOND MYOCARDIAL INFARCTION (MI) 25 DAYS AFTER THE PROCEDURE. THE PATIENT WAS TRANSFERRED FROM REHABILITATION TO AN ACUTE CAR FACILITY WITH SYMPTOMS OF CONGESTIVE HEART FAILURE. THE PATIENT WAS GIVEN INTRAVENOUS HEPARIN AND LASIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0010551

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S