BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1174205 · Received September 24, 2008

    Report

    Report Number
    9616099-2008-02323
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    December 31, 2007
    Report Date
    August 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PT. MFR REPORT# 9616099-2008-002324.

    Description of Event or Problem · 1

    FOUR YEARS POT INDEX PROCEDURE, THE PT WAS ADMITTED TO THE HOSP DURING HIS SKIING TRIP. THE PT DEVELOPED DURING SKIING, CHEST PAIN LASTING MORE THAN 30 MINUTES. ECG SHOWED A PATTERN CONSISTENT WITH ANTERIOR STEMI. THE PT WAS TREATED WITH RPA. REPEAT ECG SHOWED A RESOLVED ANTERIOR ST-ELEVATIONS, BUT A TRANSFORMATION TO INFERIOR STEMI. THE PT HAD ANGIOGRAM, WHICH DEMONSTRATED RE-STENOSIS (90%) OF MID RIGHT CORONARY ARTERY (RCA) AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AT THE SITE OF PREVIOUSLY PLACED STENTS. THE OCCLUDED STENTS WERE THEN "RE-STENTED". ECG SHOWED MILD MITRAL REGURGITATION AND A MILD LEFT VENTRICULAR DYSFUNCTION WITH AN ESTIMATED EJECTION FRACTION OF 50%. A HYPOKINETIC ANTEROSEPTAL WALL AND INFEROSEPTAL WALL WAS ALSO NOTED WITHOUT A THROMBUS SEEN. MEDICATION ON DISCHARGE: ASA 325MG, CLOPIDOGREL 75MG, METOPROLOL 100MG, RAMIPRIL 5MG, SIMVASTATIN 40MG, NITROGLYCERIN SPRAY (SL) 0.4MG. THE PT WAS DISCHARGED IN EARLY 2008 WITH THE NOTION TO SEE HIS CARDIOLOGIST BACK HOME WITHIN A MONTH TO FOLLOW-UP. THIS MALE PT HAD DIRECT STENTING PROCEDURE WITHIN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND MID RIGHT CORONARY ARTERY (RCA). A CYPHER STENT WAS DEPLOYED AT 6 ATM. IN THE LAD AND A CYPHER STENT WAS DEPLOYED AT 18 ATM. IN THE MID RCA AND BOTH LESIONS WERE SUCCESSFULLY TREATED. THE 1ST DIAGONAL WAS INTENDED AND TREATED BY BALLOON AND THE LESION WAS SUCCESSFULLY TREATED. THE PT WAS DISCHARGED HOME THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA R0203338

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 4 GUIDING CATHETER| 2 BALLOON.| 4 GUIDE WIRE