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

Model Number	2.75X35
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969)
Date of Event	06/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System not received.Stent implanted.
Event or Problem Description
It was reported on (b)(6) 2016 (late evening) by (b)(6), clinical specialist i (b)(6) that a post procedure event occurred on (b)(6) 2016 to patient from (b)(6) study.The event occurred at (b)(6) usa.The index procedure was performed on (b)(6) 2016 with nirxcell coronary stent system, catalog # nxl27533us, type 2.75x33, from lot # nus00166 and it was reported that, " event term: non-st elevation myocardial infarction"."description: subject presented with angina.Serial troponins drawn and they were elevated slightly.She was admitted.Sub - i discharged her on medication therapy.Troponin elevation thought to be from procedure".Information received on (b)(6) 2016 through (b)(6), clinical specialist i from (b)(6) ((b)(4) and data center): ((b)(4) notification).Site number: (b)(6).Site name: (b)(6).Subject number: (b)(6).Event sequence number: 1.Event term: non-st elevation myocardial infarction.Start date: (b)(6) 2016.Related to the device (as reported): possibly related.Related to the procedure (as reported): possibly related.There was no serious congenital anomaly or birth defect, no significant disability and no death.Serious criteria: hospitalization: yes; life threatening: yes; medical or surgical intervention: no.Other medically important event: yes.Information received on (b)(6) 2016 through (b)(4)'s clinical and regulatory department: the physician's name is dr.(b)(6).Gender: female.Stop date: discharged on (b)(6) 2016 on medications.Severity: severe.Outcome: resolved.We received a complaint notification via owens and minor late in the evening on (b)(6) 2016.Information received late in the evening on (b)(6) 2016 through (b)(4)'s clinical and regulatory department that was extracted from the (b)(4): the patient is (b)(6) years old.The patient did not suffer from diabetes.The lipid levels of the patient are not high.The patient does not have smoking history.The patient does not have a family history of heart disease.There is no prior history of a blocked coronary artery.The level of elevation in cardiac enzymes is: troponin i - 0.137ng/ml.

• Brand Name: NIRXCELL CORONARY STENT SYSTEM
• Common Device Name: CORONARY, STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, jerusalem 97775 08; IS 9777508
• MDR Report Key: 5805034
• Report Number: 3003084171-2016-00003
• Device Sequence Number: 345898
• Product Code: MAF
• UDI-Device Identifier: 07290107010856
• UDI-Public: 07290107010856
• 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: health professional,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2016

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: 04/30/2017
• Device Model Number: 2.75X35
• Device Catalogue Number: NXL27533US
• Device Lot Number: NUS00166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2016
• Initial Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR