BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 5104425 · Received September 25, 2015

    Report

    Report Number
    9616099-2015-00461
    Event Type
    Death
    Date Received
    September 25, 2015
    Date of Event
    August 8, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT REPRESENTS NOTIFICATION OF 4 CARDIAC DEATHS WITH STENT FRACTURE EVENTS FROM A PUBLICATION. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS OHYA, ET AL STENT FRACTURE AFTER SIROLIMUS-ELUTING STENT IMPLANTATION 8-YEAR CLINICAL OUTCOMES, CIRCULATION: CARDIOVASCULAR INTERVENTIONS (2015.) IN THE PUBLICATION BY OHYA, ET. AL. ¿STENT FRACTURE AFTER SIROLIMUS-ELUTING STENT IMPLANTATION: 8-YEAR CLINICAL OUTCOMES¿, THE AUTHORS¿ AIMED TO STUDY THE ASSOCIATION BELOW STENT FRACTURES AND ADVERSE EVENTS DURING AN EIGHT YEAR FOLLOW UP PERIOD. THE STUDY SAMPLE INCLUDED 954 PATIENTS WITH 1630 LESIONS WHO UNDERWENT CYPHER STENT IMPLANTATIONS BETWEEN 2002 AND 2005. AT THE ONE YEAR FOLLOW-UP VISIT, 92 OF THESE STENTS WERE NOTED TO BE FRACTURED. OF THE PATIENTS WITHOUT FRACTURED STENTS, 70 PATIENTS EXPERIENCED A CARDIAC DEATH, 24 DEVELOPED A MYOCARDIAL INFARCTION AND 5 DEVELOPED VERY LATE STENT THROMBOSIS. THESE PATIENTS ARE ALSO NOTED TO HAVE EXPERIENCED 119 TARGET LESION REVASCULARIZATIONS BY THE 5 YEAR FOLLOW-UP AND 32 TARGET LESION REVASCULARIZATIONS BETWEEN THE 5 AND 8 YEAR FOLLOW-UPS. OF THE PATIENTS WHO WERE NOTED TO HAVE STENT FRACTURES (N=92), 4 EXPERIENCED A CARDIAC DEATH, 9 DEVELOPED A MYOCARDIAL INFARCTION AND 6 DEVELOPED VERY LATE STENT THROMBOSIS. THESE PATIENTS ARE ALSO NOTED TO HAVE EXPERIENCED 22 TARGET LESION REVASCULARIZATIONS BY THE FIVE YEAR FOLLOW-UP AND 10 TARGET LESION REVASCULARIZATIONS BETWEEN THE 5 AND 8 YEAR FOLLOW-UPS. THE AUTHORS CONCLUDED THAT STENT FRACTURED WERE CONSISTENTLY ASSOCIATED WITH HIGHER RATES OF ADVERSE CARDIAC EVENTS DURING THE EIGHT YEAR FOLLOW-UP. THE DEVICES REMAIN IMPLANTED IN THESE PATIENTS AND ARE THUS NOT AVAILABLE FOR ANALYSIS. REVIEWS OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED WITHOUT LOT NUMBERS. WITHOUT THE RETURN OF THE DEVICES, THE REPORTED EVENTS COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE, USERS ARE CAUTIONED THAT THE USE OF DRUG-ELUTING STENTS IN PATIENTS AND LESIONS OUTSIDE THE LABELED INDICATIONS MAY HAVE AN INCREASED RISK OF ADVERSE EVENTS, INCLUDING STENT THROMBOSIS, STENT EMBOLIZATION, MYOCARDIAL INFARCTION, OR DEATH. OTHER LISTED POTENTIAL ADVERSE EVENTS INCLUDE RESTENOSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT INDIVIDUAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. WITHOUT A PRODUCT TO ANALYZE OR A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENTS WERE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 6 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2015-00461, 9616099-2015-00462, 9616099-2015-00463, 9616099-2015-00464, 9616099-2015-00465 AND 9616099-2015-00466.

    Description of Event or Problem · 1

    AS REPORTED IN THE PUBLICATION BY OHYA, ET AL STENT FRACTURE AFTER SIROLIMUS-ELUTING STENT IMPLANTATION 8-YEAR CLINICAL OUTCOMES, CIRCULATION: CARDIOVASCULAR INTERVENTIONS (2015); 1 7; THERE WERE 70 CASES OF CARDIAC DEATH, 24 CASES OF MYOCARDIAL INFARCTION, 5 CASES OF VERY LATE STENT THROMBOSIS, 119 CASES OF TARGET LESION REVASCULARIZATION AT THE 5 YEAR FOLLOW-UP, 32 CASES OF TARGET LESION REVASCULARIZATION AT THE 8 YEAR FOLLOW-UP, THERE WERE ALSO 4 CARDIAC DEATHS WITH STENT FRACTURE, 9 CASES OF MI AND STENT FRACTURE, 6 CASES OF VERY LATE STENT THROMBOSIS WITH STENT FRACTURE, 22 CASES PF RESTENOSIS AND FRACTURE AT THE 5 YEAR FOLLOW UP, 10 CASES OF RESTENOSIS WITH STENT FRACTURE AND 41 CASES OF STENT FRACTURE WITHOUT AN ADVERSE EVENT IN THE CYPHER ARM OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633990 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R