BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1103743 · Received August 8, 2008

    Report

    Report Number
    2024168-2008-00643
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT IN 2008, PRE-DILATATION WAS DONE WITH A 2.0 VOYAGER BALLOON. THREE ATTEMPTS WERE MADE TO DELIVER TWO OF ANOTHER COMPANY'S STENTS AND A XIENCE V; HOWEVER, THE SYSTEM'S DID NOT CROSS THE LESION. ANOTHER ATTEMPT WAS MADE TO INTRODUCE A 2.5X28 MULTI LINK VISION STENT; HOWEVER, IT DID NOT CROSS THE LESION. FORCE WAS USED WHEN AN ATTEMPT WAS MADE TO REMOVE THE SYSTEM AND A DISSECTION OCCURRED. UPON REMOVAL OF THE SYSTEM, IT WAS NOTICED THAT A STENT STRUT WAS BENT. A 1.5 VOYAGER WAS USED TO TREAT THE DISSECTION. AN ATTEMPT WAS MADE TO INTRODUCE A 2.0X23 VISION; HOWEVER, IT WOULD NOT CROSS THE LESION. WHEN THE SYSTEM WAS REMOVED, IT WAS FOUND TO BE HELD INSIDE THE SHEATH. THE PT WAS TREATED WITH A BALLOON ONLY AND NO STENT WAS IMPLANTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7090731

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention INFLATION: MEDTRONIC| STENT: CYPHER| DILATATION CATHETER: VOYAGER