BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153424 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02175
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    November 20, 2007
    Report Date
    August 11, 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; HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURINGPROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFO WAS REQUESTED AND REVIEWED FOR CORONARY STENT THROMBOSIS TO THE COATING SITE AND INVESTIGATION REVEALED THAT NO ANOMALIES WERE FOUND. DURING THE FINAL ASSEMBLY OF THIS LOT, 5 UNITS WERE REJECTED, THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER CORONARY SDS/STENTS DISTRIBUTED IN THE UNITED STATES. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PT AND REPORTED UNDER MANUFACTURING NUMBER 9616099-2008-02174. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY, 20 MONTHS POST STENTING PROCEDURE, THE PT DEVELOPED CHEST PAIN AND ACUTE MYOCARDIAL INFARCTION; A CORONARY ANGIOGRAM (CAG) IDENTIFIED THROMBUS AT THE STENTED SITE. THE REPORT REC'D INDICATED THAT THE PROCEDURE INCLUDED TREATMENT OF A LESION IN THE LEFT ANTERIOR DESCENDING (LAD); THE LESION EXTENDED FROM THE MID TO THE PROXIMAL LAD AND WAS 40 MM LONG WITH A 3.3 MM REFERENCE VESSEL DIAMETER. THE DE NOVO LESION WAS DESCRIBED AS A CALCIFIED CHRONIC TOTAL OCCLUSION WITH 0 TIMI FLOW. LESION CLASSIFICATION TYPE WAS C. DURING THE PROCEDURE, THE LESION WAS PRE-DILATED TO 12 ATMOSPHERES FOR APPROX 30 SECONDS. THEN TWO CYPHER STENTS WERE IMPLANTED. THE FIRST 3.0 X 23 MM CYPHER STENT WAS IMPLANTED IN THE MID LAD THEN THE 3.5 X 23 MM WAS DEPLOYED IN THE PROXIMAL LAD. BOTH STENTS WERE DEPLOYED AT 16 ATMS FOR 30 SECONDS IN AN OVERLAPPING FASHION. POST DILATION WAS NOT CONDUCTED; INTRAVASCULAR ULTRASOUND WAS CONDUCTED. POST PROCEDURE THE LESION PRESENTED 0% STENOSIS AND TIMI III FLOW. APPROXIMATELY, 20 MONTHS POST STENTING PROCEDURE, THE PATIENT COMPLAINED OF CHEST PIAN AND WAS BROUGHT TO THE HOSP AS AN EMERGENCY. THE PT DEVELOPED ACUTE MYOCARDIAL INFARCTION. A CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED FROM THE PROXIMAL EDGE TOWARDS DISTAL AREA INSIDE THE IMPLANTED CYPHER. TO TREAT THE THROMBUS, BALLOON ANGIOPLASTY WAS CONDUCTED WITH A 2.5 X 20 MM VOYAGER BALLOON, AND THEN A 3.5 X 16 MM TAXUS STENT WAS IMPLANTED INSIDE THE INITIALLY IMPLANTED CYPHER. ACCORDING TO THE PHYSICIAN THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT TICLOPIDINE HYDROCHLORIDE WAS STOPPED DUE TO THAT THE PT'S CONDITION. HOWEVER, WAS IN GOOD CONDITION AT THE RECENT FOLLOW-UP.

    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 I0106065

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R MEDICATIONS INCLUDED ASPIRIN| AND HEPARIN| TICLOPIDINE HYDROCHLORIDE| ANTI-PLATELET THERAPY WAS NOT CONDUCTED| DEVICES PRESTAGE 2.5X15MM PRE-DILATION BALLOON| CATHETER