BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 748693 · Received August 10, 2006

    Report

    Report Number
    2024168-2006-00494
    Event Type
    Injury
    Date Received
    August 10, 2006
    Date of Event
    May 25, 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 #1005635-08J; LOT #5041831 INDICATED IN THE EVENT DESCRIPTION IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER. RESULTS AND CONCLUSION SUMMATION: ENGINEERING REVIEWED THE INCIDENT INFO. 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: TWO STENTS WERE REPORTED TO BE RESTENOSED, REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT AFTER TWO PIXEL STENTS WERE IMPLANTED, IN-STENT RESTENOSIS WAS OBSERVED IN BOTH OF THE STENTS (THE DATE OF RESTENOSIS WAS NOT REPORTED). ANGIOPLASTY WAS PERFORMED USING ANOTHER COMPANY'S BALLOON CATHETER. THEN, TWO DRUG-ELUTED STENTS FROM ANOTHER COMPANY WERE IMPLANTED. NO ADD'L EVENT OR PT INFO 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 5092731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention STENT: CYPHER 2.5-23| MULTI-LINK RX PIXEL CORONARY STENT SYSTEM| PART# 1005635-08J, LOT # 5041831| DILATATION CATHETER: MAVERICK 2 2.5-20 (BOSTON)