BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 837751 · Received April 11, 2007

    Report

    Report Number
    9616099-2007-00665
    Event Type
    Injury
    Date Received
    April 11, 2007
    Date of Event
    March 9, 2007
    Report Date
    March 18, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT PRESENTED TO THE CARDIAC CATHETERIZATION UNIT AND 2-VESSEL DISEASE WAS FOUND. ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS FIRST PERFORMED ON A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) OF 20MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. THE (B2) CONCENTRIC LESION WAS AT A BIFURCATION WITH A DE NOVO LESION IN THE 1ST DIAGONAL OF 10MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THIS (B2) LESION WAS ECCENTRIC. PRE-DILATION WAS CONDUCTED WITH A 2.5X15MM BALLOON AT 8 ATMOSPHERES (ATM) BEFORE DEPLOYING TWO STENTS BY Y STENTING TECHNIQUE. FIRST DEPLOYED WAS A 3.0X23MM CYPHER STENT AT 16 ATM IN THE PROXIMAL LAD AND A 2.5X18MM CYPHER STENT AT 16 ATM. INTRAVASCULAR ULTRASOUND (IVUS) WAS CONDUCTED. RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI I AND III FLOWS WERE RECORDED PRE AND POST-PROCEDURE RESPECTIVELY. POST-DILATION WAS CONDUCTED WITH A 3.0X23MM BALLOON AT 6 ATM BY KISSING BALLOON TECHNIQUE. ACT WAS NOT MEASURED. INTRA-PROCEDURE MEDICATIONS HEPARIN 10000 UNITS. POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 100MG/DAY AND TICLOPIDINE HYDROCHLORIDE 200MG/DAY. TWO DAYS LATER, THE PT COMPLAINED OF CHEST PAIN AND RETURNED TO THE HOSP. CORONARY ANGIOGRAPHY WAS CONDUCTED AND THROMBUS WAS OBSERVED IN TWO CYPHER STENTS. TO TREAT THE THROMBUS, ASPIRATION AND PLAIN OLD BALLOON ANGIOPLASTY WAS CONDUCTED. THE PHYSICIAN COMMENTED THAT THE POSSIBLE CAUSES OF THE THROMBOTIC EVENT WERE BECAUSE THE STENTS WERE IMPLANTED BY Y-STENTING AND ANTI-PLATELET THERAPY WAS STARTED ON THE DAY OF THE PROCEDURE. PLEASE NOTE THAT THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS NOT AVAILABLE FOR TESTING AND EVAL. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITED UNDER THE FOLLOWING MFG NUMBER 9616099-2007-00664.

    Description of Event or Problem · 1

    TWO DAYS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PT COMPLAINED OF CHEST PAIN. ANGIOGRAPHY REVEALED THROMBUS WITHIN THE TWO IMPLANTED CYPHER STENTS.

    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 I1206030

    Patients

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