BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 764869 · Received September 20, 2006

    Report

    Report Number
    2024168-2006-00547
    Event Type
    Injury
    Date Received
    September 20, 2006
    Date of Event
    August 29, 2006
    Report Date
    August 29, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    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. THROMBOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM (SDS) QUALITY PROBLEM.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: SUB-ACUTE THROMBOSIS (SAT) REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE STENT WAS IMPLANTED IN 2006. 12 DAYS LATER, AN ANGIOGRAPHY WAS PERFORMED AND CONFIRMED SUB-ACUTE THROMBOSIS (SAT) HAD OCCURRING FROM THE MIDDLE PART OF THE STENT TOWARDS THE PROXIMAL PART OF THE STENT. THE LESION WAS DILATED WITH ANOTHER COMPANY'S 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 CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 5082331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention GUIDE WIRE: ATHLETEGTSOFT| GUIDING CATHETER: 7F ZUMA JL4