BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3652758 · Received February 28, 2014

    Report

    Report Number
    9616099-2014-00130
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    January 14, 2014
    Report Date
    February 6, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE PUBLICATION BY OTSUKA ET AL PATHOLOGY OF SECOND-GENERATION EVEROLIMUS-ELUTING STENTS VERSUS FIRST-GENERATION SIROLIMUS- AND PACLITAXEL-ELUTING STENTS IN HUMANS. THERE WERE 14 CASES OF STENT THROMBOSIS, 9 CASES OF RESTENOSIS, 11 CASES OF MALPOSITION, 2 CASES OF STENT FRACTURE-RELATED RESTENOSIS, AND 2 CASES OF STENT FRACTURE-RELATED THROMBOSIS IN THE CYPHER ARM OF THE AUTOPSY STUDY. THE PRODUCTS WERE IMPLANTED AND ARE THUS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. CALCIFIED LESIONS ARE A COMMON CAUSE OF STENT UNDER EXPANSION WHICH SIGNIFICANTLY INCREASES THE SUBSEQUENT RISK OF IN-STENT THROMBOSIS. THE IFU INSTRUCTS THAT ALL EFFORTS SHOULD BE TAKEN TO ASSURE THAT THE STENT IS NOT UNDER DILATED. SEPARATION OF STENT STRUTS FROM THE INTIMAL SURFACE OF THE ARTERIAL WALL OVER TIME ALSO KNOWN AS LATE STENT MALPOSITION. THERE IS A THEORETICAL CONCERN THAT INCOMPLETE STENT APPOSITION IN THE MIDDLE OF THE STENT CAN RESULT IN AREAS OF ¿CUL-DE-SAC¿ FORMATION WITH BLOOD-FLOW STAGNATION THAT CAN PREDISPOSE THE PATIENT TO STENT THROMBOSIS. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, IT IS UNKNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: OTSUKA ET AL (2014). PATHOLOGY OF SECOND-GENERATION EVEROLIMUS-ELUTING STENTS VERSUS FIRST-GENERATION SIROLIMUS- AND PACLITAXEL-ELUTING STENTS IN HUMANS. CIRCULATION 26, 211- 223. THE LITERATURE PUBLICATION HAS BEEN ATTACHED TO THIS MDR REPORT. THIS MDR REPORT IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00130, 9616099-2014-00131, 9616099-2014-00132, 9616099-2014-00133 AND 9616099-2014-00134.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY OTSUKA ET AL PATHOLOGY OF SECOND-GENERATION EVEROLIMUS-ELUTING STENTS VERSUS FIRST-GENERATION SIROLIMUS- AND PACLITAXEL-ELUTING STENTS IN HUMANS. THERE WERE 14 CASES OF STENT THROMBOSIS, 9 CASES OF RESTENOSIS, 11 CASES OF MALAPPOSITION, 2 CASES OF STENT FRACTURE-RELATED RESTENOSIS, AND 2 CASES OF STENT FRACTURE-RELATED THROMBOSIS IN THE CYPHER ARM OF THE AUTOPSY STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123802 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S