BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082250 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01841
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE COMPLAINT CONCLUSION WAS CORRECTED/UPDATED, AS ALL OF THE EVENTS THAT WERE PREVIOUSLY REPORTED WERE NOT MENTIONED IN THE INITIAL COMPLAINT CONCLUSION. THEREFORE, A NEW CONCLUSION WAS DONE TO ENCOMPASS ALL OF THE REPORTED EVENTS. A (B)(6) FEMALE CALLED FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. THE PATIENT RECEIVED TWO CYPHER STENTS IN AN UNKNOWN CORONARY VESSEL/S, A 2.5X13MM AND A 2.5X23MM CYPHER STENTS DURING THE INDEX PROCEDURE. INFORMATION ABOUT THE VESSEL/LESION CHARACTERISTICS AND THE PROCEDURE WERE NOT AVAILABLE. INITIALLY, THE PATIENT REPORTED THAT FIVE YEARS AFTER STENT IMPLANTATION, THE PHYSICIAN TOLD HER THAT THE STENTS WERE 80% BLOCKED, AFTER A STRESS TEST WAS PERFORMED. SHE IS UNSURE HOW THE 80% BLOCKAGE WAS TREATED AND REPORTED THAT A FOLLOW UP WAS SCHEDULED IN TWO MONTHS. ADDITIONAL INFORMATION RECEIVED VIA PHONE CONTACT, THE PATIENT ALSO STATED THAT SHE HAD A MYOCARDIAL INFARCTION AND STENT BLOCKAGE APPROXIMATELY 7 DAYS POST-INDEX PROCEDURE. THESE EVENTS WERE REPORTED AS MI AND STENT THROMBOSIS. SHE WAS UNSURE HOW SHE WAS TREATED. THE PATIENT'S MEDICAL HISTORY INCLUDES CORONARY ARTERY DISEASE, HYPERTENSION AND DIABETES MELLITUS. THIS PATIENT'S HISTORY PUTS HER AT INCREASED RISK FOR MACE. MEDICAL THERAPY REPORTED INCLUDED ASPIRIN, PLAVIX, TOPROL XL AND ENALAPRIL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS, MI AND THROMBOSIS, INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. THE IFU WARS THAT THE USE OF THIS DEVICE CARRIES THE ASSOCIATED RISKS OF SUB-ACUTE THROMBOSIS, VASCULAR COMPLICATIONS AND/OR BLEEDING EVENTS. BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS. HOWEVER, THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES AND HYPERTENSION) AND THE PATIENT'S PROGRESSION OF CORONARY ARTERY DISEASE THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. 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

    PT CALLED FOR MEDICAL INFO AND ADDITIONALLY REPORTED AN ADVERSE EVENT. PT HAD 2 CYPHER STENTS IMPLANTED IN AND UNKNOWN CORONARY VESSEL IN 2003. PT STATES THAT IN 2008, "I HAD A STRESS TEST LAST WEEK AND THE DOCTOR SAID, MY ONE OF MY STENTS IS 80% BLOCKED". AS TREATMENT, PT IS SCHEDULED FOR CATHETERIZATION AND TARGET LESION REVASCULARIZATION THE FOLLOWING MONTH. PHYSICIAN IS AWARE OF THESE EVENTS. NO FURTHER INFO AVAILABLE.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POSSIBLE INFECTION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention