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

Model Number 3.5X38MM

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Stenosis (2263)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The event occurred in (b)(6) as part of (b)(6) clinical study: elunir ridaforolimus eluting coronary stent system high bleeding risk (hbr) - (b)(6) study.On (b)(6) 2019 the subject was admitted to the hospital with acute coronary syndrome and st-elevation myocardial infarction (stemi).Coronary angiography showed a diseased vessel in the rca/rpda/rpl.Index procedure was on (b)(6) 2019 with implantation of an elunir stent (lot# lnrce00337) to the proximal rca and a second stent (lot# lnrce00225) to the distal rca, both target lesions.On (b)(6) 2019, approximately 4 days post index procedure, the subject experienced chest pain and on admission was found to be in complete av block with st elevation in ii, ii, avf (stemi).The subject underwent emergent pci with angiography showing 100% stenosis of mid rca.Ivus showed the proximal portion of the 3.5x38mm stent (lot# lnrce00337) was under deployed.Thrombus was also seen.The event is associated only with the proximal rca implanted stent, size 3.5x38mm (lot# lnrce00337).Actions taken following the event were as follows: infusion of intracoronary glycoprotein iib/iiia (gp iib/iiib) inhibitor was initiated.An export catheter was used but only minimal thrombus was aspirated.The subject received additional gp iib/iiib.Coronary revascularization to the mid rca with pre-dilatation and drug eluting balloon to the stent was performed.The stenosis resolved to 0% with restoration of coronary flow.The subject converted from complete heart block to sinus tachycardia with resolution of st elevation.(related sae#2- inferior st segment elevation myocardial infarction).The subject received a loading dose of ticagrelor 180 mg.He was previously on dapt (clopidogrel and aspirin) and this was switched to ticagrelor plus aspirin.Post procedure troponin was 602 ng/l (1130 ng/l on (b)(6) 2019 from a previous hospital discharge).On (b)(6) 2019 ekg showed inferior q-wave and t-wave inversion.The subject was also noted to have bibasilar crepitus.He was started on furosemide 40 mg daily and bisoprol was increased to 5 mg daily post mi.On (b)(6) 2019 his echocardiogram showed moderate ejection fraction between 40-45%.His furosemide was discontinued and was discharged home on (b)(6) 2019.Patient outcome: recovered.The investigator considered the event of stent thrombosis and consequent inferior stemi severe, not related to the procedure, related to the device and resolved on (b)(6) 2019.Initial assessment by (b)(6) medical reviewer: stent thrombosis of the right coronary artery possibly related to the device and the procedure.It will be confirmed by the cec and review of the angiographic data.It was anticipated but will be referred to the cec.Following to cec meeting held on (b)(6) 2020 it was decided by the cec members that the tevent is related to study device.

Manufacturer Narrative

Dhr (device history records) review (dated apr.16, 2020) indicated that the product was supplied meeting specifications.Ifu (instructions for use) review (dated apr.28, 2020) indicated that no deviation of ifu was reported.Angiogram analysis (dated apr.07, 2020) indicated that: 1.The rca is occluded with thrombus in the middle of the proximal stent.2.The mid portion of the sent appears under-expanded.3.2 wires are passed through the rca.4.The flow is restored and multiple balloon inflations are performed in the proximal stent.5.The distal stent is patent, balloons are inflated in this stent as well.6.Final angio shows timi 3 flow.Based on medinol's interventional cardiologist opinion (dated apr.22, 2020), acute st is usually the result of a mechanical problem.In this case, stent under-expansion is a contributory cause.Final report overall conclusions (dated apr.28, 2020): 1.The review of the dhr (device history record), along with the information from the customer indicate that the product was supplied meeting specifications.2.Stent thrombosis and myocardial infarction 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 clear conclusion about the root cause of the reported adverse event.However, in the opinion of medinol's interventional cardiologist, under-deployment of the stent in the index procedure was a contributory cause.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.

• Brand Name: ELUNIR RIDAFOROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDINOL LTD; beck-tech bldg.; har hotzvim b, 8 hartom st.,; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 9915257
• MDR Text Key: 196795986
• Report Number: 3003084171-2020-00005
• 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
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2020
• Device Model Number: 3.5X38MM
• Device Catalogue Number: LUN350R38CE
• Device Lot Number: LNRCE00337
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 71