BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2182979 · Received July 28, 2011

    Report

    Report Number
    3003742446-2011-00376
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    May 17, 2010
    Report Date
    July 6, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00376 AND 3003742446-2011-00377. INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, CORONARY ARTERY BYPASS GRAFT SURGERY, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, DEEP VEIN THROMBOSIS WITH GREENFIELD FILTER PLACEMENT, ARTHRITIS, CORONARY ARTERY DISEASE, URINARY TRACT INFECTION, RENAL LITHIASIS, SHINGLES, AND ALLERGIES TO PENICILLIN, CEPHALOSPORINS, ZITHROMAX, ZOCOR, VICRYL SUTURE, AND VASOTEC. THE INDICATION FOR THE PROCEDURE WAS ANGINA. THE TARGET LESION WAS LOCATED IN THE FIRST DIAGONAL. THE LESION WAS DESCRIBED AS DE NOVO, TYPE C, 15MM IN LENGTH, NON-THROMBOSED, AND 90% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND MODERATELY TORTUOUS. THE LESION WAS PRE-DILATED WITH A VOYAGER BALLOON CATHETER AT 8ATMS AND THE FIRST 2.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 12ATMS. A SECOND 2.5X18MM CYPHER RX STENT WAS IMPLANTED SEPARATE FROM THE FIRST STENT AT 12ATMS. NO POST-DILATION WAS DONE. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. EIGHT HOURS AFTER THE PROCEDURE, THE CK AND TROPONIN I WERE 159 (ULN 143) AND 1.28 (ULN 0.1) RESPECTIVELY. FIFTEEN HOURS AFTER THE INDEX PROCEDURE, THE CK AND TROPONIN WERE 221 AND 4.35 RESPECTIVELY. 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. ELEVATED CARDIAC ENZYMES ARE A COMMON RESULT OF IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION IN THE REPORTED EVENT OR THE DOCUMENTATION HISTORY OF A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00376 AND 3003742446-2011-00377. 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 15109748 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED AN ELEVATED CARDIAC ENZYMES EIGHT HOURS AND FIFTEEN HOURS AFTER THE INDEX PROCEDURE. THE INDICATION FOR THE PROCEDURE WAS ANGINA AND CORONARY ARTERY DISEASE. EIGHT HOURS AFTER THE PROCEDURE, THE CK AND TROPONIN I WERE 159 (ULN 143) AND 1.28 (ULN 0.1) RESPECTIVELY. FIFTEEN HOURS AFTER THE INDEX PROCEDURE, THE CK AND TROPONIN WERE 221 AND 4.35 RESPECTIVELY. THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT FELL THAT RESULTED IN BILATERAL ELBOW FRACTURES. THE TARGET LESION WAS LOCATED IN THE FIRST DIAGONAL. THE LESION WAS DESCRIBED AS DE NOVO, TYPE C, 15MM IN LENGTH, NON-THROMBOSED, 90% STENOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND MODERATELY TORTUOUS. THE LESION WAS PRE-DILATED WITH A VOYAGER BALLOON CATHETER AT 8ATMS AND THE FIRST 2.5X18MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 12ATMS. A SECOND 2.5X18MM CYPHER RX STENT WAS IMPLANTED SEPARATE FROM THE FIRST STENT AT 12ATMS. NO POST-DILATION WAS DONE. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. EIGHT HOURS AFTER THE PROCEDURE, THE CK AND TROPONIN I WERE 159 (ULN 143) AND 1.28 (ULN 0.1) RESPECTIVELY. FIFTEEN HOURS AFTER THE INDEX PROCEDURE, THE CK AND TROPONIN WERE 221 AND 4.35 RESPECTIVELY. THIRTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT TRIPPED ON RAG WHILE PAINTING AND HAD BILATERAL ELBOW FRACTURES. THE PATIENT UNDERWENT SURGERY AND WAS TRANSFERRED TO A SKILLED CARE FACILITY. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT.

    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 15109748

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other VOYAGER BALLOON 2.5 X 12MM