BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1192111 · Received October 7, 2008

    Report

    Report Number
    9616099-2008-02399
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT AND REPORTED UNDER MFG NUMBERS: 9616099-2008-02398. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    ACUTE THROMBOSIS. THE INTENDED PROCEDURE WAS AN ELECTIVE CASE TO TREAT A LESION IN THE MID AND DISTAL LEFT ANTERIOR DESCENDING (LAD). DURING THE PROCEDURE THE LESION WAS PRE-DILATED TO 16 ATMOSPHERES (ATM) FOR 15 SECONDS. THEN A 2.5X23MM CYPHER STENT WAS DEPLOYED AT 16 ATMS FOR 15 SECS, THEN PROXIMALLY TO THE FIRST STENT, A 3.0X13MM CYPHER STENT WAS DEPLOYED TO 16 ATMS FOR 20 SECONDS. POST TREATMENT, THE LESION PRESENTED A 25% RESIDUAL STENOSIS. THE VESSEL REMAINED WITH TIMI III PRE AND POST PROCEDURE. AFTER THE PROCEDURE, THE PT COMPLAINED OF CHEST PAIN. A CORONARY ANGIOGRAM WAS CONDUCTED AND THROMBOSIS WAS OBSERVED INSIDE THE IMPLANTED STENTS. THE PHYSICIAN SUSPECTED HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) AND THEREFORE, STOPPED ADMINISTRATING HEPARIN. ARGATROBAN WAS ADMINISTERED INTRAVENOUSLY INSTEAD. HOWEVER, THE THROMBI WOULDN'T STOP FORMING. ANGIOPLASTY WAS CONDUCTED AGAIN A MICRO DRIVER STENT WAS IMPLANTED INSIDE THE SECOND CYPHER. FURTHER INFO PROVIDED BY THE PHYSICIAN INDICATED THAT THE PT DID NOT HAVE HIT BECAUSE THROMBOSIS FORMATION DID NOT STOP AFTER STOPPING THE ADMINISTRATION OF HEPARIN. THEREFORE, THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE LIPID CORE WAS STICKING OUT BETWEEN THE STRUT OF THE 2ND CYPHER STENT.

    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 13402699

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R HEPARIN| ANTI-PLATELET THERAPIES CONDUCTED WERE THE| FOLLOWING: ASPIRIN| TICLOPIDINE| HYDROCHLORIDE SARPOGRELATE HYDROCHLORIDE