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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDINOL LTD. ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT

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MEDINOL LTD. ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 3.5X20
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969)
Event Date 10/25/2019
Event Type  Injury  
Manufacturer Narrative
As the event include information on two (2) sizes of the elunir product and since each mdr present only one (1) product, this report is related to one (1) out of two (2) elunir's products, involved in this event. The second device is included in report 3003084171-2020-00002. Instructions for use and device history records review are anticipated. Procedural cd/angiograms for the case were received and sent for analysis.
 
Event Description
The event occurred as part of medinol's clinical study in (b)(6): elunir ridaforolimus eluting coronary stent system high bleeding risk(hbr) - elunir hbr study. On (b)(6) 2019, the subject underwent the index procedure with implantation of elunir stents (lots lnrin00362 (which is reported under 3003084171-2020-00002) and lnrin00418) to each of the target lesions 1st obtuse margin (95% to 0%) and mid circumflex (70% to 0%) respectively. The guide wire used (unknown brand) for both lesions was with diameter of 0. 01. The guide catheter used (unknown brand) in both lesions was with a size of 6f. On (b)(6) 2019, the day following the procedure the subject experienced chest pain associated with elevated troponin at 3539 pg/ml (10-34. 20 reference range) and subsiding to 2216 pg/ml on 26 oct 2019 with "no dynamics on ecg". It was determined that the subject suffered a peri-procedural mi. The subject was placed on close observation. No additional intervention was taken for the event. The event resolved without further complaints of angina. The subject was discharged home on (b)(6) 2019. The investigator considered the event of peri-procedural mi moderate in severity and not related to the device or procedure. Baim safety medical review assessment: periprocedural mi possibly related to the device and possibly related to the procedure. It was anticipated due to underlying disease. Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that below listed event is related to study device.
 
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Brand NameELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, jerusalem 97775 08
IS 9777508
Manufacturer (Section G)
MEDINOL LTD.
beck tech bldg
8 hartom st.
jerusalem, jerusalem 97775 08
IS 9777508
Manufacturer Contact
marina demishtein
kiryat atidim
bldg. 8
tel aviv, 61581-01
IS   6158101
MDR Report Key9902647
MDR Text Key195095078
Report Number3003084171-2020-00003
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P170008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2021
Device Model Number3.5X20
Device Catalogue NumberLUN350R20IN
Device Lot NumberLNRIN00418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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