BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021192 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00809
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    December 13, 2007
    Report Date
    March 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THIS IS ONE OF THREE REPORTS SUBMITTED FOR RELATED EVENTS. PLEASE REFERENCE MFR REPORT#S: 9616099-2008-00809, 9616099-2008-00812, AND 9616099-2008-00813. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A MALE PATIENT WITH A HISTORY OF HYPERTENSION AND HYPERLIPIDEMIA WAS ADMITTED FOR CORONARY EVALUATION. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. THE PATIENT WAS CURRENTLY TAKING NO KNOWN CARDIAC MEDICATIONS. ALL BASELINE LABS AND VITAL SIGNS MEASURED WERE WITHIN NORMAL LIMITS. ANGIOGRAPHY REVEALED A 90%, 14MM DE NOVO, IRREGULAR, ECCENTRIC, B1-TYPE LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS 2.75 MM IN DIAMETER AND WAS MODERATELY TORTUOUS. PLAVIX AND INTEGRILIN WERE ADMINISTERED. INTRA PROCEDURE. THE LESION WAS PREDILATED WITH A 2.5 X 12MM BALLOON INFLATED TO 8ATMS. A 3.0 X 23MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 16 ATMS WITH SUBOPTIMAL RESULTS. DURING DEPLOYMENT, THE BALLOON RUPTURED RESULTING IN A DISTAL EDGE, TYPE-A DISSECTION. A 3.0 X 18MM CYPHER SELECT PLUS STENT WAS PLACED TO COVER THE DISSECTION AND WAS DEPLOYED TO 12 ATMS. TO ENSURE FULL EXPANSION, THE STENT WAS POST DILATED WITH A 3.25 X 25MM BALLOON INFLATED TO 26 ATMS. FOLLOWING POST DILATION THE VESSEL PERFORATED AND IT WAS NOTED THAT THE DISSECTION WORSENED TO A TYPE-C DISSECTION AND EXTENDED DISTALLY. ANOTHER 3.0 X 08MM CYPHER SELECT PLUS STENT WAS PLACED TO COVER THE DISSECTION AND WAS DEPLOYED TO 16 ATMS. TO ENSURE FULL EXPANSION, THE STENT WAS POST DILATED WITH A 3.25 X 15MM BALLOON INFLATED TO 20 ATMS. THE TYPE C DISSECTION AGAIN EXTENDED FURTHER DOWN THE VESSEL. A 2.75 X 13 MM CYPHER SELECT PLUS STENT WAS POSITIONED TO COVER THE DISSECTION AND WAS DEPLOYED TO 20 ATMS. THE STENT WAS NOT POST DILATED. NO PERICARDIAL DRAINAGE WAS REQUIRED. THE EVENTS RESOLVED WITHOUT SEQUELAE. A SECOND LESION WAS TREATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS WAS AN 80%, 24MM, DE NOVO, IRREGULAR, ECCENTRIC, B1-TYPE STENOSIS. THE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.5 X 12MM BALLOON INFLATED TO 8 ATMS. A 2.75 X 28MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 20 ATMS. TO ENSURE COMPLETE EXPANSION, THE STENT WAS POST DILATED WITH A 3.0 X 12MM BALLOON INFLATED TO 20 ATMS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY IN STABLE CONDITION WITH ORDERS FOR DAILY ADMINISTRATION OF PLAVIX. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA 13301301

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R 3.25 X 25MM BALLOON| PLAVIX| 3.0 X 18MM CYPHER SELECT PLUS| 3.0 X 23MM CYPHER SELECT PLUS| 2.5 X 12MM BALLOON| INTERGILIN| 3.0 X 08MM CYPHER SELECT PLUS| 2.75 X 13MM CYPHER SELECT PLUS| 3.25 X 15MM BALLOON