BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 929216 · Received October 17, 2007

    Report

    Report Number
    9616099-2007-02043
    Event Type
    Death
    Date Received
    October 17, 2007
    Date of Event
    September 21, 2007
    Report Date
    September 22, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED INDICATED THAT THE INDEX PROCEDURE WAS AN EMERGENT CASE WITH THE INDICATION BEING CHEST PAIN AND COMPLETE HEART BLOCK (CHB). THE TARGET LESION WAS THE OSTIAL LAD. THE LESION WAS REPORTED TO BE: SLIGHTLY CALCIFIED, CONCENTRIC, AND TYPE A. THE LESION WAS PRE-DILATED WITH A MEDTRONIC SPRINTER 2.0 X10 MM BALLOON AT 10 ATM/30 SEC. A CYPHER SELECT PLUS 2.5 X 23 MM STENT WAS IMPLANTED AT 16 ATM/45 SEC. THE STENT WAS NOT POST-DILATED. A SATISFACTORY RESULT WAS OBTAINED. THERE WAS NO RESIDUAL STENOSIS REPORTED AND THE FLOW POST-PROCEDURE WAS TIMI 3. IVUS WAS NOT DONE. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN AND WAS IN COMPLETE HEART BLOCK (CHB). A CYPHER SELECT PLUS 2.5 X 23 MM STENT WAS IMPLANTED IN THE OSTIAL LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH AN EXCELLENT RESULT AND TIMI 3 FLOW POST-PROCEDURE. A BARE METAL STENT (BMS) WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) DURING THE SAME PROCEDURE WITH A SATISFACTORY RESULT. THREE (3) DAYS AFTER THE PROCEDURE, THE PT HAD A PACEMAKER IMPLANTATION DUE TO THE PT'S EPISODE OF CHB. ASPIRIN WAS STOPPED ONE (1) DAY PRIOR TO THE PACEMAKER SURGERY AND PLAVIX (ANTIPLATELET THERAPY) CONTINUED AT BD DOSAGE (TWICE/DAY). ONE (1) WEEK AFTER THE INDEX PROCEDURE, ON THE DAY THE PT WAS SCHEDULED FOR DISCHARGE FROM THE HOSPITAL, THE PT HAD A MASSIVE MYOCARDIAL INFARCTION (MI) AND EXPIRED BEFORE BEING BROUGHT BACK TO THE CATH LAB. THE PT'S LAST ECG DEMONSTRATED ST-SEGMENT ELEVATION IN THE ANTERIOR WALL. THERE WAS NO ANGIOGRAPHIC CONFIRMATION OF THROMBOSIS OF EITHER THE CYPHER SELECT PLUS OR BMS. NO AUTOPSY WAS PERFORMED.

    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 13240727

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| L DRIVER 3.5 X 18 MM BARE METAL STENT (BMS)| MEDTRONIC SPRINTER 2.0 X 10 MM BALLOON