BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1932715 · Received December 20, 2010

    Report

    Report Number
    3003742446-2010-00465
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTED SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00465 AND 3003742446-2010-00466.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15212190 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO REPORTED SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00465 AND 3003742446-2010-00466.

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED DUE TO STABLE ANGINA AND A POSITIVE STRESS TEST. ANGIOGRAPHY REVEALED A 90%, 8MM, DE NOVO LESION IN THE DISTAL RCA AND A 90%, 9MM, DE NOVO LESION IN THE PDA. THE LESION IN THE PDA WAS PREDILATED WITH A 2.5 X 12MM VOYAGER BALLOON INFLATED TO 12 ATMS. A 3.0 X 18MM CYPHER STENT WAS DEPLOYED IN THE PDA TO 16 ATMS WITHOUT COMPLICATION. THE STENT WAS POST DILATED PER STANDARD PROCEDURE WITH A 3.5 X 6MM BALLOON INFLATED TO 20 ATMS. THEN A 3.0 X 13MM CYPHER STENT WAS POSITIONED IN THE DISTAL RCA AND WAS DEPLOYED TO 14 ATMS. THE STENTS WERE NOT OVERLAPPING. THE STENT WAS NOT POST DILATED. AT 16-24 HOURS POST PROCEDURE, THE PATIENT EXPERIENCED A RISE IN CARDIAC ENZYMES: CK 177 (300 ULN) AND CK-MB 12.36 (ULN 6.0). THE PATIENT WAS DIAGNOSED WITH NSTEMI. THIS IS BELIEVED TO BE THE RESULT OF CLOSURE OF A SMALL SIDE BRANCH DUE TO STENT PLACEMENT. THE EVENT WAS MANAGED MEDICALLY AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH NO ANGINA COMPLAINTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS PT HAD EXPERIENCED A SYNCOPAL EPISODE AND WAS ADMITTED TO THE HOSPITAL. DEVICE EVAL NOTED THREE SECOND PACING PAUSES AND THIS RIGHT VENTRICULAR DEXTRUS LEAD WAS FOUND TO BE MICRODISLODGED. THEREFORE, A REVISION PROCEDURE WAS PERFORMED, AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15212190

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other VOYAGER BALLOON 2.5 X 12MM BALLOON