BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3031712 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01933
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THE LOT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED PROXIMAL LEFT MAIN ARTERY, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND PRE-DILATATION WAS PERFORMED USING A 2.5X12 NC TREK BALLOON. THE NUMBER OF INFLATIONS AND ATMOSPHERES IS UNKNOWN. A 2.5X12 RX MINI VISION STENT SYSTEM WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. DURING POSITIONING OF THE STENT SYSTEM AT THE TARGET SITE, RESISTANCE WAS FELT WITH THE ANATOMY AND THE STENT DISLODGED FROM THE BALLOON. NO FORCE WAS APPLIED TO THE STENT SYSTEM PRIOR TO STENT DISLODGEMENT. THE STENT SYSTEM WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE AND TWO BALANCE MIDDLEWEIGHT GUIDE WIRES WERE ADVANCED TO SUCCESSFULLY RETRIEVE THE DISLODGED STENT FROM THE ANATOMY. THE PATIENT REMAINED STABLE THROUGHOUT. THE PROCEDURE WAS POSTPONED UNTIL THE FOLLOWING DAY IN WHICH THE TARGET LESION WAS SUCCESSFULLY STENTED WITHOUT ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135145 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2091841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention INTRAVASCULAR ULTRASOUND