BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1961919 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00335
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. CEREBROVASCULAR ACCIDENT (STROKE) IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT ASSOCIATED WITH THE USE OF THE PRODUCT. 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). THE RX ACCUNET (1011649-55, 9120951) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS CEREBROVASCULAR ACCIDENT (STROKE), DISSECTION AND ISCHEMIA ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE PRODUCT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT DURING THE ACCULINK STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT WITH LEFT HEMIPARESIS. THERE WAS NO REPORTED TREATMENT GIVEN. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2010, CONDITION REMAINS UNCHANGED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED THAT THE NEUROLOGICAL CHANGES OCCURRED IMMEDIATELY AFTER THE PRE-DILATATION. DUE TO THE LARGE AMOUNT OF DEBRIS THAT WAS FILLING THE RX ACCUNET AND WAS ASPIRATED, AN EMBOLIC STROKE WAS SUSPECTED. A SECOND STENT WAS DEPLOYED DUE TO A SUSPECTED EDGE DISSECTION THAT WAS POSSIBLY LIMITING THE FLOW. FLOW WAS RESTORED ONCE SEVERAL ASPIRATIONS WERE PERFORMED AND THE RX ACCUNET WAS REMOVED. ADDITIONALLY THE PATIENT WAS TREATED WITH HEPARIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 0030961

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R| S BIVALIRUDINRX ACCUNET