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

Model Number	3.0X17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr was reviewed: all manufacturing and release test documentation is present and meets requirements.Crimping, crossing profile, nesting and securement measurements are all in compliance with requirements.All the released systems met specifications.Angiogram analysis: based on the angiogram analysis observation, the classification should be: clinical -symptom-finding-outcome, restenosis, intra-stent, after the procedure ->1 month.Ifu review: no deviation of ifu was reported.Overall conclusions of the final report: the review of the dhr indicates that the product was within specifications when it was released for marketing.There is no evidence to suggest there were any manufacturing issues that contributed to the reported events.Stent restenosis is a potential post-procedure complication associated with coronary stenting of nirxcell ifu.On (b)(6) 2018, the event was resolved and the subject was discharged to a rehab facility.
Event or Problem Description
The complaint was reported on (b)(6) 2018 (late afternoon at 16.25) as post procedure event occurred on (b)(6) 2017 to a patient, participating in the (b)(6) clinical study.The index procedure that was performed on (b)(6) 2016 with nirxcell¿ coronary stent system.On (b)(6) 2017, stenosis in the mid lad lesion was shown on angiography at the clinical study site.Additional data, received on apr 04, 2018: on (b)(6) 2017, due to (b)(6) study, 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 80% stenosis, no calcification and residual stenosis post stent deployment was 10% with timi 3 flow.Lvef was 50% on (b)(6) 2016.On (b)(6) 2017 the subject was evaluated for an ascending aortic aneurysm repair and was referred for coronary angiography.The angiography showed a moderate lesion within the mid lad.60-70% stenosis at the site of the first septal branch.The down going lad had luminal irregularity.The lad gives rise to 2 small diagonal branches that had luminal irregularity.Fractional flow reserve (ffr) measurement of the mid lad showed 0.80 after given 200 mcg of adenosine.Subsequently, a repeat angiography showed no evidence of dissection or perforation.The subject tolerated the procedure well and left the cath lab in stable condition.A tr band was applied over the right radial access site for hemostasis.It was recommended to proceed with aortic root surgery and cardiac artery bypass graft (cabg) with left internal mammary artery (lima) to left anterior descending (lad).On (b)(6) 2018 the subject was hospitalized and underwent a hemi arch and ascending aorta replacement with intergard woven 34mm graft, cardiac artery bypass graft (cabg) x 1 with left internal mammary artery (lima) to left anterior descending (lad) and an open reduction and internal fixation of the sternum with the biornet plate.There were no complications and the subject was transferred to icu in stable condition.On (b)(6) 2018, the event was resolved and the subject was discharged to a rehab facility.In the investigator's opinion, the event of bypass of coronary artery (cass#: 13) was considered severe in intensity, related to the study device and unrelated to the study procedure.The sponsor considers the event of bypass of coronary artery (cass#: 13) anticipated, possibly related to the study device and unrelated to the index procedure.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 7722005
• Report Number: 3003084171-2018-00038
• Device Sequence Number: 848639
• Product Code: MAF
• UDI-Device Identifier: 07290107010887
• UDI-Public: 07290107010887
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2018

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: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 3.0X17
• Device Catalogue Number: NXL30017US
• Device Lot Number: NUS00155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2018
• Initial Report FDA Received Date: 07/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 135