BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212592 · Received October 24, 2008

    Report

    Report Number
    9616099-2008-02525
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS MALE EXPERIENCED DISSECTION DURING THE IMPLANTATION OF A CYPHER SELECT+ STENT. MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA AND OBESITY. DURING THE INITIAL PROCEDURE, A 2.75/18 MM AND A 3.5/18 MM WERE IMPLANTED IN THE MID-LAD AT 14 AND 16 ATM (RESPECTIVELY) WITH A GAP BETWEEN THE STENTS. THE TARGET SITE WAS DESCRIBED AS A TYPE B2 LESION: ECCENTRIC WITH 18 MM LESION LENGTH WITH 87% STENOSIS. IN THE DATABASE, IT APPEARS THAT THE SMALLER STENT MAY HAVE CREATED A DISSECTION DURING IMPLANTATION THAT WAS TREATED WITH THE LARGER STENT. AS NOTED, "DISSECTION UPSTREAM THEREFORE GAP IN STENTS". THE PT WAS DISCHARGED ON ASA AND PLAVIX AND REMAINED ASYMPTOMATIC AT THE 1-MONTH F/U. THE 6-MONTH F/U NOTE IN THE DATABASE STATED, "REPEAT ELECTIVE ANGIOGRAPHY PERFORMED DUE TO ONGOING STABLE ANGINA ON EXERTION". NO ADD'L INTERVENTION WAS PERFORMED. THE PROD WAS NOT RETURNED FOR ANALYSIS; IT REMAINED IMPLANTED. A REVIEW OF THE MFG RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. VESSEL DISSECTION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE AVAILABLE INFO SUGGESTS PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    EIGHTY-NINE DAYS POST INDEX PROCEDURE THE PT HAD A REPEAT ANGIOGRAPHY PERFORMED, AS HIS ANGINA WOULD NOT IMPROVE. THE PT WAS INITIALLY ENROLLED IN THE STUDY IN 2008, WITH 2-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE LESION TREATED WAS IN THE MID LEFT ANTERIOR DESCENDING BRANCH. THE LESION HAD 87% STENOSIS AND WAS DE NOVO, SMOOTH AND ECCENTRIC. THE LESION WAS 18 MM IN LENGTH AND THE VESSEL WAS 3.34 MM IN DIAMETER A 2.75 X 18 MM CYPHER SELECT STENT WAS ELECTIVELY IMPLANTED AT 14 ATM. IT WAS NOTED THAT THE LESION WAS POST-DILATED DUE TO A DISSECTION. THEN A 3.5 X 18 MM CYPHER SELECT STENT WAS IMPLANTED AT 16 ATM, TO TREAT THE DISSECTION. THE PT'S BASELINE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS. THE PT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND HEPARIN. THE PT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention THE FOLLOWING PRODUCTS WERE USED DURING THE| A 6F GUIDING CATHETER| AND A 3.0 X 8 MM BALLOON CATHETER.| A TRAVERSE GUIDEWIRE| PROCEDURE: