BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1961540 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00294
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SUPPLEMENTAL IS BEING FILED TO CORRECT THE NAME OF THE STENT THAT WAS LISTED IN THE NARRATIVE. IT WAS AN ACCULINK STENT, NOT AN XACT STENT AS INITIALLY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. HEPARIN. EMBOLIC PROTECTION: RX ACCUNET ((B)(4), LOT # 9092251) THERE WAS NO REPORTED PRODUCT DEFICIENCY. HEMORRHAGE IS LISTED IN THE PRODUCT INSTRUCTION FOR USE AS A KNOWN POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 THAT AN ACCULINK STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DAYS AFTER THE IMPLANTATION OF THE XACT STENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE THAT WAS CONFIRMED WITH A CT SCAN OF THE HEAD. THE PATIENT UNDERWENT A LEFT POSTERIOR FRONTAL CRANIOTOMY WITH THE EVACUATION OF THE INTRACEREBRAL HEMATOMA. THE PATIENT IS RECOVERING AT THE HOSPITAL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 9112051

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R| S