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

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.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY 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 Key: 9902647
• MDR Text Key: 195095078
• Report Number: 3003084171-2020-00003
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• 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 Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2021
• Device Model Number: 3.5X20
• Device Catalogue Number: LUN350R20IN
• Device Lot Number: LNRIN00418
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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