BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1358273 · Received March 13, 2009

    Report

    Report Number
    2024168-2009-00428
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 16, 2009
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY; SHAFT SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE/SHAFT SEPARATION. IT WAS REPORTED THAT THE LESION WAS IN THE MID RCA WITH STENOSIS ACUTE STEMU INFERIOR. ANOTHER COMPANY'S CATHETER WAS USED FIRST IN THE CALCIFIED LESION. A VISION STENT WAS DEPLOYED IN THE MID RCA AND INFLATED TO 10 ATM. ON THE SECOND INFLATION, THE BALLOON RUPTURED AT 10 ATM. THE BALLOON WAS PULLED OUT; HOWEVER, BECAME STUCK ON THE GUIDING CATHETER. THE WHOLE SYSTEM WAS THEN REMOVED THROUGH THE RIGHT RADIAL SHEATH. DIFFICULTY WAS EXPERIENCED WHEN REMOVING THE SYSTEM THROUGH THE SHEATH; THEREFORE, AN ATTEMPT WAS MADE TO PULL OUT THE SYSTEM AND THE BALLOON CAME OUT IN TWO PARTS. AS A RESULT, THE FEMORAL ARTERY WAS CANNULATED [A NEW SHEATH HAD TO BE INTRODUCED] TO COMPLETE HE PROCEDURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR SHEATH: TERUMO| STENT: VISION| DILATATION CATHETER: QUANTUM| GUIDE WIRE: HTF| GUIDE CATHETER: JR4 MEDTRONIC| INFLATION: MEDTRONIC