BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1162753 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02247
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE THE [ANTIPLATELET THERAPY] WAS STOPPED TWO YEARS AFTER STENT IMPLANTATION, AND AN ISR HAD OCCURRED IN THE IMPLANTED CYPHER STENT, CAUSING IT EASIER FOR THE VESSEL TO BECOME OCCLUDED. ANTI-PLATELET THERAPY WAS CONDUCTED AS FOLLOWS: ASPIRIN 200 MG/DAY 2004-2005, 100 MG/DAY: 2005-2006, 2008. TICLOPIDINE HYDROCHLORIDE 200 MG/DAY: 2004-2006, 2008, WARFARIN POTASSIUM (THE DOSE WAS UNK) 2004-2005. HEPARIN 5,000U:2004. ASPIRIN AND TICLOPIDINE HYDROCHLORIDE WERE STOPPED APPROX AT AROUND 2006 THIS CYPHER PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PCI, HYPERTENSION, AND ABNORMALITY OF LIPID METABOLISM WAS ADMITTED FOR ELECTIVE CORONARY EVAL. ANGIOGRAPHY REVEALED A DE-NOVO, ECCENTRIC LESION IN THE OSTIUM OF THE PROXIMAL LAD. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE B2. THE LESION LENGTH WAS 18MM AND VESSEL DIAMETER WAS 3.5MM. FLOW THROUGH THE VESSEL WAS TIMI III. PRE-DILATATION WAS CONDUCTED WITH A BALLOON (3.75/15MM) INFLATED TO 6 ATM FOR 10 SECONDS. A CYPHER (3.5/18MM) STENT WAS DEPLOYED TO 12 ATM FOR 30 SECONDS. POST-DILATATION WAS CONDUCTED WITH A BALLOON (4.0/8MM) INFLATED TO 18 ATM FOR 15 SEC. IVUS WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS 0%. TIMI FLOW WAS III AFTER THE PROCEDURE. ACT WAS NOT MEASURED. APPROX. 47 MONTHS POST INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND WENT TO THE HOSPITAL. ANGIOGRAPHY REVEALED A THROMBOSIS AND IN-STENT RESTENOSIS OF THE PREVIOUSLY IMPLANTED CYPHER STENT IN THE PROXIMAL LAD. THE THROMBUS WAS TREATED WITH ASPIRATION THROMBECTOMY AND THE RESTENOSIS WAS ADDRESSED WITH BALLOON ANGIOPLASTY. FINALLY, TAXUS (3.0/32MM) STENT WAS IMPLANTED WITHIN THE CYPHER STENT IN THE PROXIMAL LAD.

    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 I0804065

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R