BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 2982456 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01169
    Event Type
    Death
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 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. DEATH IS A KNOWN ADVERSE EVENT AS LISTED IN THE VISION INSTRUCTIONS FOR USE. 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. THE ADDITIONAL ADVERSE PATIENT EFFECTS AND DEVICE MALFUNCTION REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. ARTICLE, RESULTS OF STENT-ASSISTED VS NON-STENT-ASSISTED ENDOVASCULAR THERAPIES IN 489 CEREBRAL ANEURYSMS: SINGLE-CENTER EXPERIENCE.

    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
    86864 MULTI-LINK VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death