BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ SCHATZ STENT UNKNOWN

    MDR report key: 1161263 · Received September 12, 2008

    Report

    Report Number
    9610978-2008-00231
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    June 12, 2007
    Report Date
    August 21, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PALMAZ SCHATZ STENT. THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT# 9616099-2008-02224, & 9616099-2008-02225. THE PRODUCT REMAINED IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE STUDY INDICATED THAT A 61 YEAR OLD MALE UNDERWENT IMPLANTATION OF A 3.00 X 28MM CYPHER SELECT PLUS STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 3.00 X 18MM CYPHER SELECT PLUS STENT IN THE PROXIMAL CIRCUMFLEX. THE LAD WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED PALMAZ SCHATZ STENT. AT THE SIX MONTH FOLLOW-UP IN LATE 2007, THE PT HAD ANGINA. IN EARLY 2008, THE PT COMPLAINED OF ANGINA, AN ANGIOGRAM SHOWED THAT THE STENTS IN THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING ARTERY (LAD) WERE STILL WIDELY PATENT, BUT A NEW DISEASE HAD DEVELOPED, NAMELY A CRITICAL STENOSIS IN THE DISTAL PART OF THE MAIN STEM. THE PT WAS ADVISED TO HAVE CABG. THE EVENT WAS GRADED AS UNRELATED TO THE IMPLANTED CYPHER STENTS. THE STENOSIS IN THE DISTAL LEFT MAIN WAS WITHIN 4-5MM OF THE IMPLANTED CYPHER STENTS. THIS WILL BE CAPTURED AS PERI-STENT RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ SCHATZ STENT UNKNOWN NONE MAF CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R CLOPIDOGREL