BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 3870766 · Received June 12, 2014

    Report

    Report Number
    2024168-2014-03784
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LOOSE STENT WAS CONFIRMED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT FOR LOOSE STENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, THE 5.0X18MM MULTI-LINK ULTRA STENT WAS NOTED TO BE LOOSE ON THE BALLOON. THERE WAS NO ISSUE, REPORTED, WITH REMOVING THE PROTECTIVE SHEATH FROM THE STENT. WHEN IT WAS NOTICED THAT THE STENT WAS LOOSE ON THE BALLOON, AN ATTEMPT WAS MADE TO PUSH IT BACK ONTO THE BALLOON, BUT INSTEAD, THE STENT DISLODGED. THE DISLODGED STENT WAS THEN PUT BACK ON THE BALLOON AND THE DEVICE SET ASIDE FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER 4.5X18MM MULTI-LINK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347599 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3081641

    Patients

    Seq Age Sex Outcome Treatment
    1