BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 2982487 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01170
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    November 10, 2012
    Report Date
    February 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION . DATE OF IMPLANT ESTIMATED AS 30 DAYS PRIOR TO DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION, NEUROLOGICAL DEFICIT/DYSFUNCTION, PERFORATION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE VISION INSTRUCTIONS FOR USE. 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. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH AND THE DEVICE MALFUNCTION REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. THE ARTICLE IS A RETROSPECTIVE REVIEW OF TREATED CEREBRAL ANEURYSMS WITH STENT-ASSISTED AND NON-STENT-ASSISTED ENDOVASCULAR THERAPIES. 225 PATIENT UNDERWENT TREATMENT WITH STENTING WITH VARIOUS STENTS INCLUDING THE VISION STENT (ABBOTT VASCULAR). COMPLICATIONS INCLUDED: STROKE (N=12), TRANSIENT ISCHEMIC ATTACK (N=21), INTRAPROCEDURAL RUPTURE (N=19), DISSECTION (N=9), STENT MIGRATION/DISPLACEMENT (N=4), DEATH (N=21). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87671 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability