BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 11627605 · Received April 7, 2021

    Report

    Report Number
    3003084171-2021-00001
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    December 7, 2020
    Report Date
    March 15, 2021
    Manufacturer
    MEDINOL LTD.
    Product Code
    NIQ
    PMA / PMN Number
    P170008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED ADDITIONAL ADVERSE EVENT ON (B)(6) 2020 WITH THE SAME DEVICE, AS REPORTED AS PART OF REPORT # 3003084171-2020-00010 (LNRIN25). DHR (DEVICE HISTORY RECORDS) REVIEW (DATED MAR 22, 2021) INDICATED THAT THE PRODUCT WAS SUPPLIED MEETING SPECIFICATIONS. IFU (INSTRUCTIONS FOR USE) REVIEW (DATED MAR 22, 2021) INDICATED THAT NO DEVIATION OF IFU WAS REPORTED. OVERALL CONCLUSIONS FROM FINAL REPORT (DATED APR 05, 2021): THE REVIEW OF THE DHR (DEVICE HISTORY RECORD) INDICATES THAT THE PRODUCT WAS SUPPLIED MEETING SPECIFICATIONS. ANGINA AND RESTENOSIS INTRA-STENT ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE IMPLANTATION OF A CORONARY STENT IN CORONARY ARTERIES AND ARE LISTED AS SUCH IN SECTION 7 OF THE ELUNIR IFU. IN THIS CASE THE EVENTS WERE NOT UNANTICIPATED BASED ON THE KNOWN RISKS, INCLUDING THE PATIENT'S HISTORY OF CORONARY DISEASE. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED ADVERSE EVENTS. THE EVENTS OF THIS COMPLAINT ARE ADDRESSED IN THE ELUNIR DMFEA REPORT AND THE RISK REMAINS LOW. NO NEW RISKS WERE IDENTIFIED. THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    ON MAR. 15, 2021 THE FOLLOWING COMPLAINT WAS RECEIVED AS PART OF THE (B)(6) STUDY: ON (B)(6) 2019, THE SUBJECT WAS ENROLLED TO (B)(6) STUDY - THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH IMPLANTATION OF A SINGLE ELUNIR STENT (LOT LNRIN00458) TO THE TARGET LESION PROX LAD (80% TO 0% FINAL DIAMETER STENOSIS) AND A SECOND ELUNIR STENT (LOT LNRIN00362) TO THE TARGET LESION MID LAD (80% TO 0% FINAL DIAMETER STENOSIS) IN AN OVERLAPPING POSITION. ON (B)(6) 2020, 354 DAYS FOLLOWING THE BASELINE INDEX PROCEDURE THE SUBJECT WAS ADMITTED DUE TO UNSTABLE ANGINA. ANGIOGRAPHY DEMONSTRATED TWO-VESSEL CORONARY ARTERY DISEASE. ON (B)(6) 2020, THE SUBJECT UNDERWENT SUCCESSFUL PCI USING POBA + DEB TO THE TARGET VESSEL MID LAD AND POBA TO OST DIAGONAL. GUIDING CATHATER: 6F, GUIDE WIRE DIAMETER: 0.36MM, MAXIMUM STENT DEPLOYMENT PRESSURE: 12 ATM THE SUBJECT RECOVERED FROM THE UNSTABLE ANGINA ON (B)(6) 2020. THE INVESTIGATOR CONSIDERED THE EVENT OF UNSTABLE ANGINA AS EXPECTED SERIOUS AE, MODERATE IN SEVERITY AND NOT RELATED TO THE DEVICE OR PROCEDURE INITIAL BAIM SAFETY MEDICAL ASSESSMENT:UNSTABLE ANGINA POSSIBLE RELATED TO DEVICE, UNLIKLEY RELATED TO PROCEDURE, REFERRED TO CEC FOR ENDPOINT ADJUDICATION. THE ANGIO FILM WAS REVIEWED IN THE CEC MEETING HELD ON 21 JAN 2021, AND INSTENT RESTENOSIS WAS FOUND IN THE MID-LAD . FINAL CEC ADJUDICATION RECEIVED ON 12 MAR 2021: THE EVENT IS POSSIBLY RELATED TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526722 ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ MEDINOL LTD. 3.0X24 LNRIN00362

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization