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

Model Number 3X24

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 3003084171-2020-00003.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) - (b)(6) study.On (b)(6) 2019, the subject underwent the index procedure with implantation of elunir stents (lots lnrin00362 and lnrin00418 (lnrin00418 is reported under 3003084171-2020-00003)) to each of the target lesions 1st obtuse margin (95% to 0%) and mid circumflex (70% to 0%) respectively.The guide wire (unknown brand) used for both lesions had diameter of 0.01.The guide catheter (unknown brand) used in both lesions was in 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 (b)(6) 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.

Manufacturer Narrative

Dhr (device history records) review (dated may 10, 2020) indicated that the product was supplied meeting specifications.Ifu (instructions for use) review (dated may 27, 2020) indicated that no deviation of ifu was reported.Based on medinol's interventional cardiologist opinion the stent which occluded the tiny branch and narrowed the second larger branch almost certainly was the cause or a contributory cause of the mi.Based on this assumption, the event was related to the device described in this mdr and not to the device detailed in mdr number 3003084171-2020-00003.Final report overall conclusions (dated may 27, 2020): 1.The review of the dhr (device history record) indicates that the product was supplied meeting specifications.2.Myocardial infarction is a well-known potential adverse event that may be associated with the implantation of a coronary stent in coronary arteries and is listed as such in section 8 of the elunir ifu.3.In the opinion of medinol's interventional cardiologist, the occlusion of a tiny branch and narrowing of a second larger branch during implantation of the stent was almost certainly the cause or a contributory cause of the mi.4.The events of this complaint are addressed in the elunir dmfea report and their risks remain low.No new risks were identified.5.The patient recovered.

Manufacturer Narrative

Angiogram analysis (dated apr.07, 2020) indicated the following: 1.The rca has a 50-70% proximal lesion 2.The lad has mild disease 3.There is tight sub-occlusion of the middle portion of m1 4.There another 70% lesion in the proximal cx 5.At the site of the tight lesion there is a tiny branch, and distal to the lesion is a larger branch measuring 1-1.5mm 6.Balloons are inflated from the proximal cx to distal of the m1 lesion 7.A long stent is implanted and post-dilated in the m1 lesion covering both branches 8.A second stent is placed in the proximal cx 9.Final angiograms show good flow in the cx-m1 branch with no evidence of dissection 10.The tiny branch is occluded and there is narrowing of the second branch.

• 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
• MDR Report Key: 9902644
• MDR Text Key: 197919485
• Report Number: 3003084171-2020-00002
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2020

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 3X24
• Device Catalogue Number: LUN300R24IN
• Device Lot Number: LNRIN00362
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS.
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 90