BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3183072 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03891
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 COMPLAINT DEVICE WAS RETURNED AND ANALYZED. THE REPORTED LEAK AND INFLATION DIFFICULTY WAS CONFIRMED AND WAS LIKELY DUE TO THE CASE CIRCUMSTANCES. BASED ON RETURNED DEVICE TESTING, 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. REVIEW OF THE SIMILAR INCIDENTS COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE MULTI-LINK 8 STENT WAS ATTEMPTED TO BE PRESSURIZED WITH AN INDEFLATOR, THE STENT DELIVERY SYSTEM (SDS) BALLOON COULD NOT BE INFLATED AND BLOOD WAS NOTED TO BE BACK-FLOWING INTO THE SDS CATHETER. THE DEVICE WAS EXCHANGED FOR ANOTHER MULTI-LINK 8 STENT OF THE SAME SIZE, WHICH WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282483 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2103141

    Patients

    Seq Age Sex Outcome Treatment
    1