MAUDE Adverse Event Report: MEDINOL LTD. NIRXCELL STENT SYSTEM; COCR CORONARY STENT

Model Number	3.5X17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Sudden Cardiac Death (2510)
Date of Event	10/16/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not returned to manufacturer attached: dhr review.
Event or Problem Description
Subject id: (b)(6).Date of index procedure: (b)(6) 2016.Time to event (days): 601 days.This report is for subject (b)(6), an (b)(6) male participating in the (b)(4) study.On (b)(6) 2016, due to stable angina (ccsc ii), the subject underwent index procedure with deployment of nirxcell stent system to the middle lad target de novo, pre-procedure timi flow was grade 3 with 75% stenosis, no calcification, residual stenosis post stent deployment was 0% with timi 3 flow.Lvef was 55% on (b)(6) 2016.On (b)(6) 2017, the subject experienced cardiac arrest.The subject was brought to er by ems in full cardiac arrest with cpr in progress after subject's family reported subject passing out at home.His vital signs were 92.8 t, unlabored, 74/40.The subject was intubated, chest compressions initiated and acls protocol initiated.The subject expired in the er on (b)(6) 2017 at 11:17.In the investigator's opinion, the event of cardiac arrest was considered severe in intensity, unrelated to the study device and unrelated to the study procedure.The sponsor considered the event of cardiac arrest anticipated, possibly related to the study device and unrelated to the index procedure.Sponsor comment: the subject presented to medical facility in cardiac arrest with ongoing cpr.Idioventricular rhythm.Cause of arrest unknown.Additional information received on apr' 16th 2018: site was made aware of the sae on (b)(6) 2018 - on 2 year follow up visit - contact with the family member safety received the sae notification on (b)(6) 2018 and the investigator assessed the event as unrelated to the study device, but the medical monitor considered possibly related to the device which made the case an expedited report.The medwatch report was sent on (b)(6) 2018.Additional information received on apr' 29th 2018: no other surgeries/procedures were performed on the patient after the (b)(6) index procedure on (b)(6) 2016.There was no injury to patient during the index procedure.Additional information received on may 1st 2018: the cec adjudicated this event on (b)(6) 2018.The cec outcome was: death, cardiac.Stent thrombosis: possible.Stent thrombosis timing: very late.Device related: possibly related.Procedure related: unrelated.Additional information received on may 10th 2018: no autopsy performed.
Additional Manufacturer Narrative
Attached: nus144_ifu review; nus144_final report.
Event or Problem Description
Angiogram analysis report (dated june 7, 2018) - included the following observations: the angiogram included the following observations and conclusions: index procedure was performed on (b)(6) 2016.Lv gram shows preserved lv systolic function.Images of the rca show a dominant artery without evidence of significant atherosclerosis.The circumflex artery does not appear significantly diseased.A mid lad lesion is present of moderate severity, ivus is performed.A nirxcell stent measuring 3.5x17 mm is placed in the mid-lad just proximal to the large second diagonal branch.There does not appear to be dissection of the lad at the edges of the stent, though it should be noted that the stent appears oversized for the lad diameter.Ifu review (dated (b)(6) 2018).Final report (dated (b)(6) 2018).

• Brand Name: NIRXCELL STENT SYSTEM
• Common Device Name: COCR CORONARY STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem,, 97775 08; IS 9777508
• MDR Report Key: 7540057
• Report Number: 3003084171-2018-00023
• Device Sequence Number: 1871854
• Product Code: MAF
• UDI-Device Identifier: 07290107010955
• UDI-Public: 07290107010955
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: 3.5X17
• Device Catalogue Number: NXL35017US
• Device Lot Number: NUS00113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1. ASPIRIN 81MG QD; 2. PLAVIX 75 MG QD; 3. BYSTOLIC 5 MG QD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Weight: 81