BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 1020733 · Received March 27, 2008

    Report

    Report Number
    2024168-2008-00220
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 22, 2007
    Report Date
    February 27, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    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 - QUALITY ENGINEERING REVIEWED THE INCIDENT INFO. PER THE INSTRUCTIONS FOR USE (IFU), ONE OF THE CONTRAINDICATIONS IS, "PTS WHO HAVE EXPERIENCED A RECENT (LESS THAN ONE WEEK) ACUTE MYOCARDIAL INFARCTION." RESTENOSIS, AS LISTED IN THE RISK ASSESSMENT AND IFU IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THE MFG RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS PART/LOT NUMBER COMBINATION AND ALL TESTING MET MFG CRITERIA. ADDITIONALLY, THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION.

    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 IN 2006, THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, WHICH WAS TORTUOUS AND 99% STENOSED. THE VESSEL DIAMETER WAS 3.0MM AND THE VESSEL LENGTH WAS 20 MM. A PIXEL STENT WAS IMPLANTED. DURING A FOLLOW-UP IN 2007, RESTENOSIS WAS OBSERVED PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND ANOTHER COMPANY'S STENT WAS 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 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 5112231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R