BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1861104 · Received October 4, 2010

    Report

    Report Number
    2024168-2010-02068
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE GUIDE WIRE LUMEN WAS COLLAPSED AT THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 1.3 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE SDS WAS PRESSURIZED USING A NEW INDEFLATOR FILLED WITH RENOGRAFIN 60 DILUTED 1:1 WITH WATER. THE BALLOON DID NOT INFLATE DUE TO THE CONTRAST IN THE INFLATION LUMEN. THE CONTRAST WAS DISSOLVED AND THE BALLOON WAS PRESSURIZED TO RATED BURST PRESSURE, TO MEASURE THE DEFLATION TIMES. THE DEFLATION TIMES DID NOT MEET MANUFACTURING CRITERIA. ALTHOUGH ANALYSIS OF THE RETURNED PRODUCT NOTED THE SHAFT TO BE COLLAPSED, THERE WAS NO DAMAGE NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE; THEREFORE, THE DAMAGE LIKELY OCCURRED DURING THE PROCEDURE, AND FURTHER CONTRIBUTED TO THE DIFFICULTY DEFLATING THE BALLOON. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEPLOYMENT, THE VISION BALLOON WOULD NOT DEFLATE WITH USE OF THE INDEFLATOR. A LARGE SYRINGE HAD TO BE USED TO FINALLY DEFLATE THE BALLOON. THERE WERE NO PT EFFECTS AS A RESULT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. THIS IS BEING FILED CONSERVATIVELY BECAUSE IT COULD NOT BE CONFIRMED THAT FULL DEFLATION OF THE BALLOON WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 0061541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: TERUMO RUNTHROUGH