BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1121087 · Received August 14, 2008

    Report

    Report Number
    2024168-2008-00661
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, INTERACTIONS WITH OTHER DEVICES, INTERACTIONS WITH STENT STRUTS, PATIENT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR EXCESSIVE APPLIED PRESSURE. REPORTEDLY, THE PATIENT ANATOMY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO MECHANICALLY DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION, IT RUPTURED. HOWEVER, WITHOUT A RETURNED DEVICE FOR ANALYSIS, A DEFINITE ROOT CAUSE FOR THE RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE LESION WAS THE MID RIGHT CORONARY ARTERY (RCA) WHICH HAD MILD TORTUOSITY, MODERATE CALCIFICATION, AND 90% STENOSIS. AFTER PRE-DILATING THE LESION WITH A 2.5 X 15 MM BALLOON CATHETER, THE 3.5 X 23 MM VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. HOWEVER, WHEN THE VISION SDS WAS INFLATED FOR THE FIRST TIME TO EXPAND THE STENT, THE BALLOON RUPTURED AT 10 ATM. THE STENT WAS FURTHER DILATED USING A 3.5 X 20 MM BALLOON CATHETER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 709193Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: VISION 3.5 X 23| HIRYU 3.5-20| DILATATION CATHETER: RYUJIN PLUS 2.5-15| GUIDING CATHETER: MACH AL17F