BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2193576 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05567
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS A KNOWN ADVERSE EVENT LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU). DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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 DURING THE PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY, PRE-DILATATION WAS PERFORMED AND A 3.5 X 18 RX VISION STENT WAS SUCCESSFULLY DEPLOYED. AFTER STENT IMPLANT, A SMALL DISSECTION WAS NOTED AT THE DISTAL END OF THE STENT. A 3.5 X 12 RX VISION STENT SYSTEM WAS ADVANCED FOR TREATMENT OF THE DISSECTION; HOWEVER, THE DELIVERY CATHETER COULD NOT ADVANCE THROUGH THE PREVIOUSLY DEPLOYED VISION STENT. THE DELIVERY CATHETER WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE AND A 4.0 X 8 APEX BALLOON WAS USED TO SUCCESSFULLY TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1032141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention