BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 660745 · Received January 4, 2006

    Report

    Report Number
    2024168-2006-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2006
    Date of Event
    December 2, 2005
    Report Date
    December 5, 2005
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION QUALITY ASSURACE ANALYSIS OF THE RETURNED STENT DELIVERY SYSTEM (SDS) REVEALED THAT THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE SDS. THE OUTER DIAMETERS OF THE BALLOON WERE MEASURED USING A DIGITAL SNAP GAUGE AND AN INDEFLATOR FILLED WITH RENOGRAFIN 60 DILUTED 1:1 WITH SALINE AT 9 ATM AND THEY DID NOT MEET THE COMPLIANCE CHART SPECIFICATIONS. QUALITY ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED DEVICE. ANALYSIS CONFIRMED THAT THE PROXIMAL AND ISTAL STENT DIAMETERS AT EXPASION WERE LARGER THAT WHAT IS GIVEN ON THE COMPLIANCE CHART; HOWEVER, THERE IS NOT A SPECIFICATION FOR EXPANSION AT THE PROXIMAL OR DISTAL ENDS. THE SPECIFICATION IS FOR THE MIDDLE OF THE STENT. MANUFACTURING WAS CONTACTED AND THEY AGREED THAT THE ONLY SPECIFICATION IS FOR THE MID STENT AT NOMINAL PRESSURE, AND MEASUREMENTS TAKEN ONLINE MET SPECIFICATION. THE VALUES ON THE COMPLIANCE CHART ARE AN APPROXIMATION AND NOT A A TOLERANCE. THE CINE OF THIS PROCEDURE WAS REVIEWED AND CONCLUDED THAT THE ENDS OF THE STENT APPEARED TO BE THE SAME SIZE. IN THIS CASE, THERE APPEARS TO BE NO INDICATION OF A PRODUCT QUALITY ISSUE AND THE DIFFICULTIES EXPERIENCED APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON CONFORMITIES ASSOCIATED WITH THIS PRODUCT LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE STENT WAS IMPLANTED, IT APPEARED TO BE OVERSIZED. REPORTEDLY, THERE WAS NO PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 5052031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN