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

Model Number 3X15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Chest Pain (1776); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263); Sweating (2444); Vascular Dissection (3160)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Instructions for use and device history records review are anticipated.Angiogram analysis is also anticipated.

Event Description

The event occurred as part of medinol's clinical study: (b)(6) study - in (b)(6).On (b)(6) 2019, the subject underwent coronary angiography (3 vessel disease to lad/diagonal, lcx/om/ramus and rca/rpda/rpl) and the index procedure with implantation of a single elunir stent (lot lnrin00357) to the proximal rca target lesion (95% to 0% final diameter stenosis).Guide wire size: diameter 0.36 of an unknown brand.Guide catheter size: 6f of an unknown brand.On (b)(6) 2019, 157 days following the index procedure and while undergoing hemodialysis treatment the subject complained of severe chest pain and sweats.He was sent to the er.Ecg showed acute inferior myocardial infarction (stemi) with troponin i of 51.8 mcg/l.He was admitted and underwent a revascularization of the proximal rca target lesion with implantation of a stent with good result.The investigator has not provided the causality assessment to the device or procedure.Initial baim safety medical review: inferior wall myocardial infarction possibly related to the device and not related to the procedure.It was anticipated and resulted in apparent target lesion revascularization.It will be referred to the cec for review.The investigator considered the event of inferior wall mi (stemi) serious, severe and related to the device and procedure.The event was considered resolved on (b)(6) 2019.Following to cec meeting held on 13 feb 2020 it was decided by the cec members that below listed event is related to study device.

Event Description

Additional case details were received as part of the investigation by medinol's clinical trials project manager: correction to (b)(6) 2019 event narrative: inferior wall mi - stent thrombosis was demonstrated in the right coronary artery at the point where there are 2 previous stents (elunir& another brand).The subject was treated with ptca balloons without a stent.A good angiographic outcome was obtained, with normal flow in the artery.Follow-up baim medical safety assessment:stent thrombosis resulting in target lesion revascularization possibly related to the device and not related to the procedure.It was anticipated.Additional information: on (b)(6) 2019, this subject experienced unstable angina.Catheterization in (b)(6) 2019 showed patent stents in lcx and lad, insignificant stenosis in ostial lad; distal edge dissection was demonstrated in ostial rca at the end of the stent.Ptca with a balloon was performed, and a stent was implanted in the middle rca segment.This stent was not medinol's stent.This event was assessed by the pi as not related to the device but to the procedure.However the mm (medical monitor) assessed this as possible related to device and procedure - this event is still pending cec (clinical ethics committee) adjudication.- cardiac cath lab summary report for event of (b)(6) 2019: by radial access, stent thrombosis was demonstrated in the right coronary artery at the point where there are 2 previous stents.A guiding wire was passed, preliminary dilatation was performed, and flow was resumed.Subsequently dilatation with nc 4 balloon was performed, followed by 4.5 mm at high pressure.A good angiographic outcome was obtained, with normal flow in the artery.Diagnosis: primary pci in acute mi.Acute inferior myocardial infarction, 3-vessel coronary artery disease, s/p ptca and stent to lad patent, s/p ptca and stent to marginal patent, s/p ptca and stent to rca, stent thrombosis - sub acute, ptca to rca successful.Subject will continue with recommended dapt, lipitor, and cochicine along with cbc monitoring and aggressive control of risk factors.The patient is stable per follow-up conducted on (b)(6) 2019.

Manufacturer Narrative

Additional and corrected data was presented in section b5.Ifu (instructions for use) review (dated (b)(6) 2020) indicated that no deviation of ifu was reported.

Manufacturer Narrative

Corrected data: in the initial mdr, a udi number was detailed in section d4.However, as the cat.Number is not intended to the us market, there is no udi number to be filled in this section.Dhr (device history records) review (dated apr.16, 2020) indicated that the product was supplied meeting specifications.Angiogram analysis (dated apr.07, 2020) indicated the following: 1.Left system angio reveals patent stents in the lad and m1 2.The rca has an ostial stent which is occluded with the appearance of stent thrombosis 3.The occluded stent struts appear well expanded 4.A wire is passed and flow is restored by serial balloon inflations 5.The rca is ectatic with a calcified lesion (50%) in the mid-rca 6.Final angiogram shows timi3 flow in the entire rca.

Manufacturer Narrative

Correction to information in previous fu mdr (fu2): case investigation determined that the diagnosis attributed to oct 7 event (unstable angina and dissection) considered unrelated to the reported complaint as it is still pending clinical ethics committee (cec) adjudication.Overall conclusions from final report (dated jul.20, 2020): 1.The review of the dhr (device history record) indicate that the product was supplied meeting specifications.2.Myocardial infarction and stent thrombosis 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 8 of the elunir ifu.3.The investigation findings do not lead to a conclusion about the root cause of the reported adverse events, that occurred 157 days following the index procedure.4.The events of this complaint are addressed in the elunir dfmea report and their risks remain low.No new risks were identified.5.The events were treated by revascularization of the target lesion with ptca balloons, with good result.6.The patient recovered and was discharged from hospital a week later.

• 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: 9897900
• MDR Text Key: 196608971
• Report Number: 3003084171-2020-00004
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07290107013710
• UDI-Public: 07290107013710
• 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,Followup
• Report Date: 05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 3X15
• Device Catalogue Number: LUN300R15IN
• Device Lot Number: LNRIN00357
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 85