BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1111946 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01960
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    June 9, 2007
    Report Date
    July 15, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE ST-ELEVATION ANTERIOR MYOCARDIAL INFARCTION (STEMI) WITH ONSET OF SYMPTOMS EQUAL TO OR GREATER THAN SIX HOURS AND LESS THAN TWELVE HOURS (=>6 HOURS AND <12 HOURS). THE PT WAS FOUND TO HAVE ONE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE PROCEDURE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS NOT PROVIDED. THE TARGET LESION WAS THE PROXIMAL/MID CIRCUMFLEX. THE LESION WAS REPORTED TO BE: DE NOVO, 2.5 MM VESSEL DIAMETER, 15 MM LENGTH, A 96% STENOSIS, AND TYPE B1. THE LESION WAS NOT PRE-DILATED. A CYPHER SELECT PLUS 2.5 X 18 MM STENT WAS IMPLANTED ELECTIVELY AT 16 ATM VIA DIRECT STENTING. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PATIENT'S SIX TO TWENTY-FOUR HOUR POST-PROCEDURE CARDIAC ENZYMES WERE NORMAL. THE PT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PT WAS REPORTED TO HAVE ANGINA AT THE ONE-MONTH FOLLOW-UP AND WAS CONTINUING HIS MEDICAL REGIMEN. AT THE SIX-MONTH FOLLOW-UP, THE PT WAS REPORTED TO BE ASYMPTOMATIC, WAS CONTINUING HIS MEDICAL REGIMEN, AND REPORTED THE ABOVE ADVERSE EVENTS. 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 EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROXIMATELY TWO MONTHS AFTER THE INDEX PROCEDURE, THE PT WAS ADMITTED WITH A ST-ELEVATION, NON-Q-WAVE MYOCARDIAL INFARCTION (STEMI). CORONARY ANGIOGRAPHY WAS DONE AND THE PREVIOUSLY IMPLANTED CYPHER SELECT PLUS 2.5 X 18 MM STENT WAS OCCLUDED. THE LATE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY. THE ADVERSE EVENT (AE) WAS REPORTED TO HAVE A PROBABLE RELATIONSHIP TO THE STUDY DEVICE AND A POSSIBLE RELATIONSHIP TO THE PROCEDURE. THE SUBJECT'S EVENT OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUEL.

    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 I1106033

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R