BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3223907 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04352
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND ANALYZED. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED AND THE RETURN ANALYSIS, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A TREK BALLOON CATHETER. A 2.5 X 08 MM MINI VISION WAS ADVANCED TO THE LESION; HOWEVER THE STENT IMPLANT DISLODGED. THE STENT WAS RETRIEVED WITH A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322008 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0101441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention