BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1885224 · Received October 28, 2010

    Report

    Report Number
    3003742446-2010-00383
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    March 24, 2009
    Report Date
    October 5, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED IN-STENT RESTENOSIS OF THE STUDY STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES UNSTABLE ANGINA, PREVIOUS PCI (1995), HISTORY OF COPD, FAMILY HISTORY OF CORONARY ARTERY DISEASE, DYSLIPIDEMIA, AND HYPERTENSION. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH 99% STENOSIS, UNSTABLE ANGINA AND A (B)(4) STUDY. THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH BALLOON ANGIOPLASTY AND DELIVERY OF A 3.5 X 33 MM CYPHER BX IN THE PROXIMAL RCA. THERE WAS 14% RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE TIME OF THE 30-DAY AND 6-MONTH FOLLOW-UP VISITS, THE PATIENT WAS WITHOUT ANGINA. APPROXIMATELY (B)(6) MONTHS LATER, REPEAT ANGIOGRAPHY FOR RECURRENT ANGINA REVEALED A 75% DIFFUSE IN-STENT RESTENOSIS OF THE OSTIAL RCA. THE PATIENT UNDERWENT REVASCULARIZATION WITH PLACEMENT OF ONE TAXUS LIBERTE STENT IN THE OSTIAL RCA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED DUE TO CANCER APPROXIMATELY (B)(6) YEARS AFTER THE INDEX PROCEDURE. THIS EVENT IS UNRELATED TO THE CYPHER STENT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS, VESSEL/LESION FACTORS (RESIDUAL STENOSIS) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(6) STUDY, A PATIENT EXPERIENCED IN-STENT RESTENOSIS OF THE STUDY STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH 99% STENOSIS, UNSTABLE ANGINA AND A POSITIVE FUNCTIONAL ISCHEMIA STUDY. THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH BALLOON ANGIOPLASTY AND DELIVERY OF A 3.5 X 33MM CYPHER BX IN THE PROXIMAL RCA. THERE WAS 14% RESIDUAL STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. AT THE TIME OF THE 30-DAY AND 6-MONTH FOLLOW-UP VISITS, THE PATIENT WAS WITHOUT ANGINA. APPROXIMATELY SEVEN AND A HALF MONTHS LATER, REPEAT ANGIOGRAPHY FOR RECURRENT ANGINA REVEALED A 75% DIFFUSE IN-STENT RESTENOSIS OF THE OSTIAL RCA. THE PATIENT UNDERWENT REVASCULARIZATION WITH PLACEMENT OF ONE TAXUS LIBERTE STENT IN THE OSTIAL RCA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ACCORDING TO THE CLINICAL EVENTS COMMITTEE (CEC), THE RESTENOSIS WAS RELATED TO THE STUDY STENT, BUT NOT RELATED TO THE PROCEDURE.

    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) 13417719

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ASPIRIN, CLOPIDOGREL