BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 4760222 · Received May 8, 2015

    Report

    Report Number
    2024168-2015-02616
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    February 27, 2015
    Report Date
    September 2, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO REMOVE AND DIFFICULT TO POSITION THE DEVICE WERE CONFIRMED. THE INVESTIGATION DETERMINED THAT A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO POSITION THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE REPORTED DIFFICULT TO REMOVE APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE CROSS-IT GUIDE WIRE MENTIONED IS FILED UNDER MFR REPORT# 2024168-2015-03417.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EMERGENCY ANGIOPLASTY PROCEDURE, THE UNSPECIFIED GUIDE WIRE BECAME STUCK IN THE 2.5 X 18 MM MINI VISION STENT DELIVERY SYSTEM. THE DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE UNSPECIFIED GUIDE WIRE WAS IDENTIFIED AS A CROSS-IT GUIDE WIRE. THE DEVICES BECAME STUCK DURING ADVANCEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304509 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3121841

    Patients

    Seq Age Sex Outcome Treatment
    1