BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2974236 · Received February 22, 2013

    Report

    Report Number
    2024168-2013-01050
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DAMAGE COULD NOT BE CONFIRMED. BALLOON MATERIAL SHREDDING AND A HOLE IN THE SOFT TIP WAS NOTED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5 X 12 MM MINI VISION STENT, IT WAS NOTED THAT A FEW STRUTS OF THE STENT WERE FLARED. THE DEVICE WAS NOT USED ON THE PATIENT. THE DEVICE WAS REPLACED WITH A SIMILAR SIZED MINI VISION DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. RETURNED DEVICE ANALYSIS NOTED BALLOON PEELING AND A HOLE IN THE SOFT TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78400 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2032041

    Patients

    Seq Age Sex Outcome Treatment
    1