BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3050861 · Received April 10, 2013

    Report

    Report Number
    2024168-2013-02176
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4). 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. IT WAS REPORTED THAT RESISTANCE WAS FELT AND THE PHYSICIAN CONTINUED TO ADVANCE THE CATHETER. IT SHOULD BE NOTED THAT THE VISION INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. IN THIS CASE, THE CONTINUED CATHETER ADVANCEMENT AGAINST RESISTANCE MOST LIKELY RESULTED IN THE REPORTED CATHETER SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE TORTUOUS RIGHT CORONARY ARTERY VIA FEMORAL ACCESS, PRE-DILATATION WAS PERFORMED USING A 2.5X15 BALLOON AT 8 ATMOSPHERES. AN ATTEMPT WAS MADE TO ADVANCE A 4.0X28 RX VISION STENT DELIVERY SYSTEM. WHILE THE STENT SYSTEM WAS STILL IN THE 6F GUIDE CATHETER, RESISTANCE WAS FELT. THE PHYSICIAN CONTINUED TO ADVANCE THE STENT DELIVERY SYSTEM WITHOUT FORCE AND THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE ANATOMY. THE DEVICE WAS WITHDRAWN FROM THE ANATOMY AND AN ATTEMPT WAS MADE TO ADVANCE A NEW 4.0X28 RX VISION STENT DELIVERY SYSTEM. DUE TO VESSEL TORTUOUSITY, THE STENT DELIVERY SYSTEM COULD NOT ADVANCE AND WAS WITHDRAWN FROM THE ANATOMY. THE 6F GUIDE CATHETER WAS EXCHANGED FOR A 7F GUIDE CATHETER AND TWO SHORTER VISION STENTS WERE DELIVERED AND IMPLANTED SUCCESSFULLY TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148296 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2030841

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 6F