BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2923124 · Received January 18, 2013

    Report

    Report Number
    2024168-2013-00342
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT COULD NOT BE CONFIRMED; HOWEVER, THE STENT WAS NOTED TO BE LOOSE. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THIS 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 PREPARATION OF A VISION RX STENT DELIVERY SYSTEM (SDS), OUTSIDE THE PATIENTS ANATOMY, AS THE PROTECTIVE SHEATH WAS BEING REMOVED, THE STENT DISLODGED FROM THE SDS. THE SDS WAS SET ASIDE AND ANOTHER UNSPECIFIED SDS WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28086 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2071841

    Patients

    Seq Age Sex Outcome Treatment
    1