BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CYPHER JAPAN

    MDR report key: 7268125 · Received February 13, 2018

    Report

    Report Number
    9616099-2018-01873
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    August 31, 2017
    Report Date
    February 15, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS NOTED IN A LITERATURE PUBLICATION, FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217; REPORT THAT A (B)(6) YEAR OLD MALE PATIENT TREATED WITH A SIROLIMUS STENT IN THE SVG HAD VERY LATE STENT THROMBOSIS (VLST) 27 MONTHS AFTER PCI. THE PATIENT WAS ON THIENOPYRIDINE AT 1 YEAR AND AT THE ONSET OF THE VLST AS WELL ON ASPIRIN AT THE ONSET OF VLST. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿CORONARY STENT THROMBOSIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. ACCORDING TO THE PRECAUTIONS IN THE SAFETY INFORMATION PROVIDED IN THE INSTRUCTIONS FOR USE ¿SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATATION OF THE ARTERIAL SEGMENT CONTAINING THE STENT. THE LONG-TERM OUTCOME FOLLOWING REPEAT DILATATION OF ENDOTHELIALIZED STENTS IS NOT WELL CHARACTERIZED. TO AVOID THE POSSIBILITY OF DISSIMILAR METAL CORROSION, DO NOT IMPLANT STENTS OF DIFFERENT MATERIALS IN TANDEM WHERE OVERLAP OR CONTACT IS POSSIBLE.¿ ALSO ¿THE EXTENT OF THE PATIENT¿S EXPOSURE TO DRUG AND POLYMER IS DIRECTLY RELATED TO THE NUMBER OF STENTS IMPLANTED. USE OF MORE THAN TWO CYPHER STENTS HAS NOT RECEIVED ADEQUATE CLINICAL EVALUATION. USE OF MORE THAN TWO CYPHER STENTS WILL RESULT IN THE PATIENT RECEIVING LARGER AMOUNTS OF DRUG AND POLYMER THAN THE EXPERIENCE REFLECTED IN THE CLINICAL STUDIES.¿ ACCORDING TO A CASE STUDY AND REVIEW ARTICLE ¿COMPARED TO BMS (BARE METAL STENT) IMPLANTATION, DESS (DRUG ELUTING STENTS) ARE ASSOCIATED WITH DELAYED ARTERIAL HEALING, LOCALIZED INFLAMMATORY HYPERSENSITIVITY REACTIONS, AND INCREASED LATE STENT MALAPPOSITION WITH UNCOVERED STRUTS. AN ADDITIONAL POTENTIAL FACTOR CONTRIBUTING TO LATE THROMBOTIC EVENTS IS THE DEVELOPMENT OF NEOATHEROSCLEROSIS WITH PLAQUE RUPTURE. PREVIOUSLY REPORTED CLINICAL PREDICTORS OF PATIENTS AT INCREASED RISK FOR LATE AND VERY LATE DES THROMBOSIS INCLUDE DIABETES, ACTIVE CIGARETTE SMOKING, AND PRIOR MI (MYOCARDIAL INFARCTION). THE RISK OF ST (STENT THROMBOSIS) CONTINUES TO PERSIST BEYOND 5 YEARS AFTER FIRST-GENERATION DES IMPLANTATION. THESE SOBERING FINDINGS UNDERSCORE THE NEED FOR LONG-TERM CLINICAL VIGILANCE IN THESE PATIENTS AND REINFORCE CURRENT PCI GUIDELINES, WHICH RECOMMEND CONTINUING AT LEAST ASPIRIN INDEFINITELY.¿THE LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT DEVICE REPORTED IS A CYPHER STENT (SDS) AND FOR WHICH THE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY AVAILABLE. IF OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE PUBLICATION, FUKU ET AL IMPACT OF DUAL ANTIPLATELET THERAPY BEYOND 1 YEAR ON CLINICAL OUTCOMES OF PATIENTS WITH STENT FRACTURE OR PERI-STENT CONTRAST STAINING AFTER SIROLIMUS-ELUTING STENT IMPLANTATION; CIRC J. 2017 DEC 25;82(1):211-217; REPORT THAT A (B)(6) YEAR OLD MALE PATIENT TREATED WITH A SIROLIMUS STENT IN THE SVG HAD VERY LATE STENT THROMBOSIS (VLST) 27 MONTHS AFTER PCI. THE PATIENT WAS ON THIENOPYRIDINE AT 1 YEAR AND AT THE ONSET OF THE VLST AS WELL ON ASPIRIN AT THE ONSET OF VLST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110900 UNKNOWN CYPHER JAPAN CORONARY DRUG-ELUTING STENT NIQ CORDIS CASHEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R| S