BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 748496 · Received August 10, 2006

    Report

    Report Number
    2024168-2006-00496
    Event Type
    Injury
    Date Received
    August 10, 2006
    Date of Event
    February 2, 2006
    Report Date
    August 4, 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

    THE SECOND MULTI-LINK RX PIXEL CORONARY STENT SYSTEM, PART #1005635-18J, LOT #5040431, INDICATED IN THE EVENT DESCRIPTION AND D11, IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER. RESULTS AND CONCLUSION SUMMATION: ENGINEERING REVIEWED THE INCIDENT INFORMATION. RESTENOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM QUALITY PROBLEM.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS, REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT RESTENOSIS WAS OBSERVED AFTER TWO PIXEL STENTS WERE IMPLANTED IN 2005. ANGIOPLASTY WAS PERFORMED USING 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 PIXEL CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 5050931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PART #1005635-18J, LOT# 5040431| STENT: MULTI-LINK RX PIXEL CORONARY STENT SYSTEM| DILATATION CATHERTER: MAVERICK2 2.25-20