BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040298 · Received May 7, 2008

    Report

    Report Number
    9616099-2008-01250
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 23, 2008
    Report Date
    April 15, 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 PROCEDURE WAS AN EMERGENT CASE DUE TO AN ACUTE MYOCARDIAL INFARCTION. THE TARGET LESION WAS THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS A DE-NOVO, BIFURCATED AND FLEXION LESION. LESION CLASSIFICATION WAS TYPE C. THE LESION LENGTH WAS APPROX 40 MM AND VESSEL DIAMETER WAS 2.5-3.5MM. PRE-DILATATION WAS CONDUCTED WITH A 2.0 X 20 MM BALLOON FOR 5 SECONDS. THE 1ST 2.5 X 23 MM CYPHER STENT WAS IMPLANTED AT 16 ATMS FOR 10 SECONDS. A 2ND 3.5X18MM CYPHER STENT WAS IMPLANTED AT 16 ATMS FOR 10 SECONDS PROXIMAL TO THE 1ST CYPHER STENT AND OVERLAPPING IT. POST-DILATATION WAS NOT CONDUCTED. IVUS WAS CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS ZERO PERCENT. TIMI FLOW BEFORE THE PROCEDURE WAS 0 AND 3 AFTER THE PROCEDURE. ACT WAS UNK. THIS IS ONE OF TWO PRODS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFG REPORTS #: 9616099-2008-01249 AND 9616099-2008-01250. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    NOTIFICATION WAS REC'D FROM THE AFFILIATE INDICATING THAT APPROX THREE YRS POST INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND HE WAS BROUGHT TO THE HOSPITAL AS AN EMERGENCY. A CORONARY ANGIOGRAM WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE OVERLAPPING PORTION OF THE 1ST AND 2ND CYPHER STENTS. TO TREAT THE THROMBUS, ASPIRATION AND POBA WAS CONDUCTED WITH A BALLOON. STENT FRACTURE WAS OBSERVED IN THE OVERLAPPING PORTION BY CAG AND IVUS. A 3.0 X 16 MM TAXUS STENT WAS IMPLANTED AT THE FRACTURED PORTION. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS DUE TO FRACTURE AT THE OVERLAPPING PORTION.

    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 I0105019

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 2.0X20 MM BALLOON| 2.5X23MM CYPHER STENT