BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 4466312 · Received January 29, 2015

    Report

    Report Number
    2024168-2015-00471
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 7, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INCORRECT PREP. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE LEAK WAS CONFIRMED. 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 THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR LEAKS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, IT SHOULD BE NOTED THE MULTI-LINK 8 CORONARY STENT SYSTEM (CSS), INSTRUCTIONS FOR USE (IFU) STATES: PREPARE AN INFLATION DEVICE/SYRINGE WITH DILUTED CONTRAST MEDIUM. ATTACH AN INFLATION DEVICE/SYRINGE TO THE STOPCOCK; ATTACH IT TO THE INFLATION PORT. WITH THE TIP DOWN, ORIENT THE DELIVERY SYSTEM VERTICALLY. OPEN THE STOPCOCK TO DELIVERY SYSTEM; PULL NEGATIVE FOR 30 SECONDS; RELEASE TO NEUTRAL FOR CONTRAST FILL. CLOSE THE STOPCOCK TO THE DELIVERY SYSTEM; PURGE THE INFLATION DEVICE/SYRINGE OF ALL AIR. REPEAT STEPS UNTIL ALL AIR IS EXPELLED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL AND FIRST DIAGONAL OF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 38 MM MULTI-LINK 8 WAS DEPLOYED. A 2.5 X 28 MM MULTI-LINK 8 WAS ADVANCED TO THE LESION; HOWEVER, NEGATIVE WAS PULLED BEFORE INFLATING AND BLOOD CAME INTO THE INFLATION DEVICE. THE DEVICE WAS REMOVED AND EXCHANGED FOR ANOTHER 2.5 X 28 MULTI-LINK 8 WHEN THE STENT STRUTS FLARED POSSIBLY DUE TO INTERACTION WITH THE IMPLANTED 2.75 X 38 MULTI-LINK 8. A NON-ABBOTT STENT WAS IMPLANTED WITH THE MINI CRUSH TECHNIQUE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69023 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3011641

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: MULTI-LINK 8 2.75X38MM