BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1862204 · Received October 8, 2010

    Report

    Report Number
    3003742446-2010-00356
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 10, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS APPROXIMATELY SIX MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HER RISK FOR MACE INCLUDES HYPERTENSION, DIABETES MELLITUS, CONGESTIVE HEART FAILURE (CHF), AND CORONARY ARTERY BYPASS GRAFT SURGERY IN 2001. THE INDICATION FOR THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME (ACS) AND CHF. TWO CYPHER STENTS WERE DEPLOYED IN THE PROXIMAL CIRCUMFLEX IN OVERLAPPING MANNER. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED TWO DAYS LATER. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND CLOPIDOGREL. APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH ACS AND A CORONARY ANGIOGRAM REVEALED IN-STENT RESTENOSIS IN THE DISTAL END OF THE DISTAL IMPLANTED STENT (2.5 X 28 CYPHER) IN THE PROXIMAL CIRCUMFLEX. THE ISR WAS NOT WITHIN 5 MM OF THE CYPHER STENT IMPLANTED PROXIMALLY. A PROMUS STENT WAS DEPLOYED WITHIN THE RESTENOSED CYPHER TO TREAT THE ISR SUCCESSFULLY. 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 (SPECIFICALLY DIABETES, EXTENSIVE CAD) AND VESSEL/LESION FACTORS (LONG LESION) 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.

    Description of Event or Problem · 1

    REPORT RECEIVED REGARDING A (B)(6) WHO IS CURRENTLY PARTICIPATING IN THE (B)(6) TRIAL. ON (B)(6), 2010, DUE TO ACUTE CORONARY SYNDROME AND CONGESTIVE HEART FAILURE, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF TWO CYPHER DRUG ELUTING STENTS IN THE PROXIMAL CIRCUMFLEX ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED FROM INDEX HOSPITALIZATION ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED AN ONSET OF ACUTE CORONARY SYNDROME AND WAS ADMITTED TO THE HOSPITAL THE FOLLOWING DAY. THE ADMISSION WAS ALSO COMPLICATED BY ACUTE RENAL FAILURE. CORONARY ANGIOGRAPHY ON (B)(6), 2010 REVEALED IN STENT RESTENOSIS OF THE DISTAL STENT IN THE PROXIMAL CIRCUMFLEX. DUE TO THE PATIENT'S ACUTE RENAL FAILURE, STENTING OF THE ISR WAS NOT DONE UNTIL (B)(6), 2010. A PROMUS STENT WAS DEPLOYED WITHIN THE RESTENOSED CYPHER TO TREAT THE ISR SUCCESSFULLY. THE EVENT RESOLVED WITH THIS TREATMENT. THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON (B)(6), 2010. THE PATIENT HAD BEEN COMPLAINT WITH ALL STUDY MEDS ACCORDING TO THE SITE.

    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) 15062339

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention