BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3193378 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04023
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED INFLATION ISSUE AND KINK WERE CONFIRMED. THE REPORTED PHYSICAL RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, DISTAL LEFT ANTERIOR DESCENDING ARTERY. PREDILATATION WAS PERFORMED PRIOR TO STENTING. AFTER CROSSING THE 2.75X23 MM VISION STENT DELIVERY SYSTEM TO THE LESION, WITH SOME RESISTANCE FELT, AN ATTEMPT WAS BEING MADE TO INFLATE THE STENT; HOWEVER, WAS UNSUCCESSFUL AS A KINK HAD DEVELOPED AT THE HUB OF THE DEVICE. ANOTHER VISION STENT OF THE SAME SIZE WAS USED SUCCESSFULLY TO TREAT THE LESION. THE PATIENT IS DOING FINE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293750 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2100541

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR