BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2791764 · Received October 15, 2012

    Report

    Report Number
    2024168-2012-06515
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 30, 2012
    Report Date
    September 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS NOT CONFIRMED. DURING DEVICE ANALYSIS THE DEFLATION TIMES MET SPECIFICATIONS AND THE BALLOON COMPLETELY DEFLATED AND FOLDED FLAT. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PROXIMAL ANTERIOR DESCENDING ARTERY, THE 4.0 X 18 RX MULTI-LINK 8 BALLOON WAS INFLATED TO 12 ATMOSPHERES AND THE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. AN ATTEMPT WAS MADE TO WITHDRAW THE STENT SYSTEM; HOWEVER, RESISTANCE WAS FELT BECAUSE THE BALLOON COULD NOT BE COMPLETELY DEFLATED. EXTRA FORCE WAS APPLIED TO THE STENT SYSTEM AND THE STENT SYSTEM WAS WITHDRAWN SUCCESSFULLY WITHOUT ADVERSE PATIENT EFFECT. ALTHOUGH THERE WAS A DELAY IN THE PROCEDURE, THE DELAY WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. FOLLOW-UP APPOINTMENT CONFIRMED THAT THE TARGET LESION WAS TREATED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2030941

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR