BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3140963 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03438
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OTHER MINI VISION DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. CONCOMITANT PRODUCTS: GUIDE WIRE: WHISPER; GUIDE CATH: 6F. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, 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 MID LEFT ANTERIOR DESCENDING ARTERY. THERE WAS A SIGNIFICANT BEND IN THE ARTERY JUST PAST THE 1ST DIAGONAL. PRE-DILATATION WAS PERFORMED WITH A 2.0 X 15 MM DILATATION CATHETER. A 2.5 X 28 MM MINI VISION WAS ADVANCED TO THE LESION; HOWEVER, IT COULD NOT CROSS. THE DEVICE WAS REMOVED AND A 2.5 X 15 MM AND THEN A 2.5 X 12 MM MINI VISION WERE DEPLOYED IN THE LESION. THERE WERE NO ISSUES INFLATING OR DEFLATING THE BALLOONS; HOWEVER, THERE WAS RESISTANCE REMOVING BOTH DEVICES FROM THE ANATOMY, ALTHOUGH THEY WAS ABLE TO BE REMOVED. IT IS UNKNOWN WHAT CAUSED THE RESISTANCE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244414 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2101742

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR