BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2773217 · Received October 5, 2012

    Report

    Report Number
    9616099-2012-00562
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    August 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 8 SEPARATE EVENTS INVOLVING STENT FRACTURE WITH THE ORIGINAL CYPHER STENT PLATFORM FROM A LITERATURE REVIEW SOURCE AND FOR WHICH SPECIFIC PATIENT INFORMATION WAS NOT AVAILABLE. AN INVESTIGATION WAS CONDUCTED, BUT NO ADDITIONAL INFORMATION HAS BEEN OBTAINED YET. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT POST IMPLANTATION THE CYPHER STENTS WERE FRACTURED. THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE HAS BEEN NO STERILE LOT NUMBER INFORMATION AVAILABLE FOR ANY OF THE INVOLVED DEVICES, THUS NO DHRS COULD BE PERFORMED. STENT FRACTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. THE CYPHER STENT WAS IMPLANTED TO TREAT INSTENT STENOSIS OF A PREVIOUSLY PLACED STENT. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    PARK ET AL. INCIDENCE AND CLINICAL IMPACT OF FRACTURE OF DRUG-ELUTING STENTS WIDELY USED IN CURRENT CLINICAL PRACTICE: COMPARISON WITH INITIAL PLATFORM OF SIROLIMUS-ELUTING STENT. JOURNAL OF CARDIOLOGY 60 (2012) 215-221; REPORT THAT THERE WERE 36 STENT FRACTURES OF WHICH 28 INVOLVED RESTENOSIS OF THE ORIGINAL CYPHER STENT PLATFORM, 11 STENT FRACTURES WITH THE CYPHER SELECT AND 101 EVENTS OF RESTENOSIS WITHOUT FRACTURE WITH THE ORIGINAL DES PLATFORM. THE AUTHORS RETROSPECTIVELY ANALYZED DATA FROM THE (B)(6) REGISTRY INVOLVING THE INITIAL PLATFORM OF FIRST GENERATION DES STENTS, CYPHER BX AND TAXUS LIBERTE ALONG WITH THE CURRENT PRACTICE WITH NEWER DES PLATFORMS SUCH AS CYPHER SELECT (CS), TAXUS LIBERTE, ENDEAVOR AND XIENCE. OF THE 36 STENT FRACTURES, 22 WERE FOUND IN THE LAD, 1 IN THE LCX AND 13 WERE FOUND IN THE RCA. THE SPECIFIC VESSELS INVOLVED WITH THE RESTENOSIS AND STENT FRACTURE EVENTS WERE NOT SPECIFIED.

    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 Required Intervention