BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10982632 · Received December 10, 2020

    Report

    Report Number
    3003084171-2020-00018
    Event Type
    Death
    Date Received
    December 10, 2020
    Date of Event
    July 28, 2020
    Report Date
    November 16, 2020
    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 CASE DETAIL REPORT INDICATED THAT TWO DEVICES WERE USED IN THE PROCEDURE. SINCE IT CANNOT BE DETERMINED WHICH ONE OF THE DEVICES WAS INVOLVED THE EVENT, 2 SEPARATE MDR REPORTS ARE SUBMITTED, SEE ALSO MFR REPORT #3003084171-2020-00017. INFORMATION RECEIVED ON NOV. 12, 2020 THROUGH MEDINOL'S CLINICAL DEPARTMENT: THE REPORTED CAUSE OF DEATH IS ST-ELEVATION MYOCARDIAL INFARCTION. THERE IS EVIDENCE OF INFERIOR WALL MI DEMONSTRATED BY ECG (ST INFERIOR ELEVATION). THE MI IS IN THE TERRITORY OF THE IMPLANTED STENTS (PROX & DIST RCA). AS THIS WAS THE REASON FOR THE CEC'S CLASSIFICATION OF STENT THROMBOSIS, THE COMPLAINT WAS NOT CLASSIFIED AS MI IN ADDITION TO STENT THROMBOSIS. IT IS UNKNOWN TO WHICH OF THE TWO STENTS THE EVENT WAS POSSIBLY RELATED. DHR REVIEW FOR LOT #LNRIN00390 WAS CONDUCTED ON DECEMBER 08, 2020 AND CONCLUDED THAT THE LOT SUCCESSFULLY PASSED THE RELEASE TESTS. IFU REVIEW WAS CONDUCTED ON DECEMBER 09, 2020 :NO DEVIATION OF IFU WAS REPORTED. FINAL REPORT OVERALL CONCLUSIONS (DATED DEC. 10, 2020): THE REVIEW OF THE DHRS (DEVICE HISTORY RECORDS) INDICATES THAT THE PRODUCTS WERE SUPPLIED MEETING SPECIFICATIONS. STENT THROMBOSIS AND DEATH ARE WELL-KNOWN POTENTIAL ADVERSE EVENT 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. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE ROOT CAUSE OF THE REPORTED ADVERSE EVENTS. THEIR RELATIONSHIP TO THE ELUNIR STENTS IMPLANTED IN THE INDEX PROCEDURE WAS ADJUDICATED BY THE CEC AS "POSSIBLY RELATED". THE EVENT WAS CLASSIFIED BY THE CEC AS STENT THROMBOSIS PER THE ARC DEFINITION WITHOUT ANGIOGRAPHIC CONFIRMATION OF STENT THROMBOSIS. THE EVENTS OF THIS COMPLAINT ARE ADDRESSED IN THE ELUNIR DMFEA REPORT AND THE RISKS REMAIN LOW. NO NEW RISKS WERE IDENTIFIED.

    Description of Event or Problem · 1

    ON NOV. 16, 2020 THE FOLLOWING COMPLAINT RECEIVED AT MEDINOL, AS PART OF THE (B)(6) STUDY: ON (B)(6) 2019, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH IMPLANTATION OF TWO ELUNIR STENTS: (1) 2.5X20 MM STENT (LOT LNRIN00392) IN THE PROX. RCA. GUIDING CATHETER: 6F, GUIDE WIRE DIAMETER: 0.35MM, MAXIMUM STENT DEPLOYMENT PRESSURE: 16 ATM; (2) 2.5X17 MM STENT (LOT LNRIN00390) IN THE DIST. RCA. GUIDING CATHETER: 6F, GUIDE WIRE DIAMETER: 0.35MM, MAXIMUM STENT DEPLOYMENT PRESSURE: 12 ATM ON (B)(6) 2020, APPROXIMATELY 329 DAYS POST-INDEX PROCEDURE, THE PATIENT WAS BROUGHT TO THE HOSPITAL VIA AMBULANCE. THE FAMILY REPORTED THAT THE NIGHT BEFORE, THE PATIENT TOOK A SLEEPING PILL AND NEVER WOKE UP. THE PATIENT'S SON FOUND HER WITH AGONAL BREATHING AND CALLED THE AMBULANCE. ECG (TRACINGS NOT AVAILABLE) DEMONSTRATED ST INFERIOR ELEVATION. RESUSCITATION AND ELECTRIC SHOCK WERE DONE IN THE AMBULANCE. LATER ON, THE PATIENT HAD PULSELESS ELECTRICAL ACTIVITY (PEA), FOR WHICH MANUAL RESUSCITATION WAS PERFORMED FOR 10 MINUTES, UNTIL ARRIVAL AT THE ER. AT THE ER, ADDITIONAL RESUSCITATION WAS PERFORMED FOR 5 MINUTES, ACHIEVING RETURN OF SPONTANEOUS CIRCULATION. ECG DEMONSTRATED NO ST ELEVATIONS AND A COMPLETE ATRIAL-VENTRICULAR BLOCK (CAVB). THE GAS TEST WAS PERFORMED: PH=7.16, PCO2=50 MMHG, HCO3=17.8 MILLIEQUIVALENT/LIT,. LACTATE 10 MMOL/LIT, SODIUM 109 MMOL/LIT. AFTER A DISCUSSION WITH THE FAMILY AND THE PATIENT'S KNOWN WISHES ON HER WILL, PALLIATIVE CARE WAS STARTED. ON (B)(6) 2020 AT 22:55, THE PATIENT PASSED AWAY. THE REPORTED CAUSE OF DEATH WAS ST-ELEVATION MYOCARDIAL INFARCTION. A DEATH CERTIFICATE WAS NOT PROVIDED. THE INVESTIGATOR CONSIDERED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. INITIAL BAIM SAFETY MEDICAL ASSESSMENT: POSSIBLY RELATED TO DEVICE AND UNLIKELY RELATED TO THE PROCEDURE CEC ASSESSMENT DATED (B)(6) 2020: POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. THE STENT THROMBOSIS WAS DEFINED BY THE CEC PER ARC DEFINITION: "ANY MI, IRRESPECTIVE OF TIME AFTER BASELINE PROCEDURE, THAT IS RELATED TO DOCUMENTED ACUTE ISCHEMIA IN THE TERRITORY OF THE IMPLANTED STENT WITHOUT ANGIOGRAPHIC CONFIRMATION OF STENT THROMBOSIS AND IN THE ABSENCE OF ANY OTHER OBVIOUS CAUSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447926 ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ MEDINOL LTD. 2.5X17 LNRIN00390

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death