BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4935325 · Received July 23, 2015

    Report

    Report Number
    3003742446-2015-00044
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 9, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY LEE ET AL COMPOSITE OUTCOMES IN 2.25-MM DRUG ELUTING STENTS: A SYSTEMATIC REVIEW; CARDIOVASCULAR REVASCULARIZATION MEDICINE (2015) 237-242; THERE WERE 16 CASES OF TARGET LESION REVASCULARIZATION (AT THE 12 MONTHS FOLLOW-UP) AND 7 CASES OF TARGET LESION REVASCULARIZATION (AT THE 12-24 MONTHS FOLLOW-UP) IN THE CYPHER ARM OF THE STUDY. THERE WERE ALSO 3 CASES OF STENT THROMBOSIS (AT THE 12 MONTHS FOLLOW-UP) AND 1 CASE OF STENT THROMBOSIS (AT THE 12-24 MONTHS FOLLOW-UP) IN THE CYPHER ARM OF THE STUDY. LASTLY, THERE WERE 10 CASES OF THE MYOCARDIAL INFARCTION (AT THE 12 MONTH FOLLOW-UP) AND 3 CASES OF MYOCARDIAL INFARCTION (AT THE 12-24 MONTH FOLLOW-UP). COMPOSITE CLINICAL OUTCOME WAS DEFINED AS THE COMPOSITE OF DEATH, TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), STENT THROMBOSIS AND MI. THIS DEFINITION WAS USED IN VIEW OF THE INCONSISTENT DEFINITION AND REPORTING OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). ANGIOGRAPHIC OUTCOME WAS DEFINED BY IN-SEGMENT LLL, INSEGMENT PERCENTAGE DIAMETER RESTENOSIS AND IN-SEGMENT BINARY RESTENOSIS. A SYSTEMATIC LITERATURE SEARCH OF PUBMED, EMBASE, WEB OF SCIENCE AND COCHRANE DATABASE WAS PERFORMED FOR CLINICAL TRIALS OF 2.25-MM DES. ANGIOGRAPHIC AND COMPOSITE CLINICAL OUTCOMES WERE COMPARED WITH DESCRIPTIVE STATISTICS. 2.25 MM-PACLITAXEL (PES), SIROLIMUS (SES), EVEROLIMUS (EES) AND PLATINUM CHROMIUM EES DES-SPECIFIC OUTCOMES HAVE BEEN REPORTED. DEATH AT 12 MONTHS FOR SES, PES, EES AND PLATINUM CHROMIUM EES WAS (B)(4). RATES OF TARGET VESSEL REVASCULARIZATION AT 12 MONTHS FOR SES, PES, EES AND PLATINUM CHROMIUM EES WERE (B)(4). THERE WAS NO STERILE LOT NUMBER PROVIDED AND THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS, THEREFORE NO DHR REVIEW NOR PRODUCT ANALYSIS WILL BE CONDUCTED. TARGET LESION REVASCULARIZATION, STENT THROMBOSIS, MYOCARDIAL INFARCTION ARE ALL WELL DOCUMENTED EVENTS FOLLOWING STENT IMPLANTATION. WITHOUT FURTHER TESTING, IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THESE EVENTS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO SPECIFIC DEVICE OR DEMOGRAPHIC INFORMATION. LITERATURE CITATION: LEE, ET AL. (2015). COMPOSITE OUTCOMES IN 2.25-MM DRUG ELUTING STENTS: A SYSTEMATIC REVIEW. CARDIOVASCULAR REVASCULARIZATION MEDICINE, 237-242.

    Description of Event or Problem · 1

    AS REPORTED BY LEE ET AL COMPOSITE OUTCOMES IN 2.25-MM DRUG ELUTING STENTS: A SYSTEMATIC REVIEW; CARDIOVASCULAR REVASCULARIZATION MEDICINE (2015) 237-242; THERE WERE 16 CASES OF TARGET LESION REVASCULARIZATION (AT THE 12 MONTHS FOLLOW-UP) AND 7 CASES OF TARGET LESION REVASCULARIZATION (AT THE 12-24 MONTHS FOLLOW-UP) IN THE CYPHER ARM OF THE STUDY. THERE WERE ALSO 3 CASES OF STENT THROMBOSIS (AT THE 12 MONTHS FOLLOW-UP) AND 1 CASE OF STENT THROMBOSIS (AT THE 12-24 MONTHS FOLLOW-UP) IN THE CYPHER ARM OF THE STUDY. LASTLY, THERE WERE 10 CASES OF THE MYOCARDIAL INFARCTION (AT THE 12 MONTH FOLLOW-UP) AND 3 CASES OF MYOCARDIAL INFARCTION (AT THE 12-24 MONTH FOLLOW-UP). COMPOSITE CLINICAL OUTCOME WAS DEFINED AS THE COMPOSITE OF DEATH, TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), STENT THROMBOSIS AND MI. THIS DEFINITION WAS USED IN VIEW OF THE INCONSISTENT DEFINITION AND REPORTING OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). ANGIOGRAPHIC OUTCOME WAS DEFINED BY IN-SEGMENT LLL, INSEGMENT PERCENTAGE DIAMETER RESTENOSIS AND IN-SEGMENT BINARY RESTENOSIS. A SYSTEMATIC LITERATURE SEARCH OF PUBMED, EMBASE, WEB OF SCIENCE AND COCHRANE DATABASE WAS PERFORMED FOR CLINICAL TRIALS OF 2.25-MM DES. ANGIOGRAPHIC AND COMPOSITE CLINICAL OUTCOMES WERE COMPARED WITH DESCRIPTIVE STATISTICS. 2.25 MM-PACLITAXEL (PES), SIROLIMUS (SES), EVEROLIMUS (EES) AND PLATINUM CHROMIUM EES DES-SPECIFIC OUTCOMES HAVE BEEN REPORTED. DEATH AT 12 MONTHS FOR SES, PES, EES AND PLATINUM CHROMIUM EES WAS (B)(4). RATES OF TARGET VESSEL REVASCULARIZATION AT 12 MONTHS FOR SES, PES, EES AND PLATINUM CHROMIUM EES WERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478658 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1