BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1953267 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00164
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 12, 2010
    Report Date
    December 13, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. DIL CATH: VOYAGER, AVIATOR; EMBOLIC PROTECTION: EMBOSHIELD NAV 6, HEPARIN. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF PROLAPSE AND NON-SURGICAL TREATMENT ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PRODUCT NO FAULT RISK ASSESSMENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED TISSUE PROLAPSE AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. RX ACCULINK CAROTID STENT SYSTEM, (PART 1011340-30, LOT 9120351) REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE AN ACCULINK STENT (PART 1011343-40, LOT 0041461) WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY AND POST-DILATATION WAS DONE USING A NON-ABBOTT BALLOON. ANGIOGRAM FOLLOWING POST-DILATATION SHOWED A SHELF OF ATHEROMATOUS PLAQUE JUST PROXIMAL TO THE STENT. THEREFORE, AN ACCULINK STENT (PART 1011340-30, LOT 9120351) WAS PREPARED TO COVER THE PLAQUE; HOWEVER, DURING PREPARATION THE TIP OF THE STENT DELIVERY SYSTEM BROKE OFF ON THE TABLE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A THIRD ACCULINK STENT WAS SUCCESSFULLY IMPLANTED PROXIMALLY AT THE BIFURCATION TO TREAT THE PLAQUE SHELF. AN ADDITIONAL STENT WAS THEN IMPLANTED IN THE RIGHT COMMON CAROTID ARTERY, AS PLANNED, TO COVER THE LONG INDEX LESION. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY AND THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS 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 0041461

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention FOR CONCOMITANT MEDICAL PRODUCTS