BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2120349 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04107
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 25, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. THE PRODUCT USED DURING THE PROCEDURE WAS NOT RETURNED WHICH MAY HAVE AIDED IN THE DETERMINATION OF THE CAUSE. A STENT MIGRATION MAY BE A RESULT OF, BUT IS NOT LIMITED TO, PATIENT VESSEL GEOMETRY, THE VESSEL DIAMETER WHICH COULD HAVE BEEN LARGER THAN THE STENT, INADEQUATE STENT APPOSITION TO THE VESSEL WALL AFTER DEPLOYMENT, INADVERTENT MOVEMENT OF THE HANDLE DURING DEPLOYMENT, OR SUBOPTIMAL POSITIONING OF THE STENT PRIOR TO DEPLOYMENT. THE ACCULINK INSTRUCTIONS FOR USE STENT DEPLOYMENT CAUTIONS THAT PRIOR TO STENT DEPLOYMENT, ALL SLACK SHOULD BE REMOVED FROM THE DELIVERY SYSTEM. A REVIEW OF MANUFACTURING RECORDS DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER REPORTED INCIDENTS WITH THIS PART AND LOT NUMBER COMBINATION WHICH SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON AVAILABLE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCULINK MIGRATED DURING DEPLOYMENT IN THE MILDLY CALCIFIED LEFT INTERNAL CAROTID ARTERY REQUIRING A SECOND ACCULINK TO COVER THE REST OF THE LESION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 0121461

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EMBOLIC PROTECTION: RX ACCUNET