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

Model Number	3.0X17
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Chest Pain (1776); Stenosis (2263)
Date of Event	09/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
On (b)(6) 2016 event received from (b)(4) study.Initial description: "patient c/o cp (chest pain) in office on (b)(6) 2016 & set for heart cath on (b)(6) 2016, instent restenosis found in study stent & re-stented to rca".Outcome: recovered/resolved.Additional information on dec 20, 2016: the target vessel was rca: cass (coronary artery surgery segment) 3 -dist rca.The index procedure was performed on (b)(6) 2016.The doctor for index procedure and for re-stenting was dr.(b)(6).The patient came in first in pain on (b)(6) 2016, and again on (b)(6) 2016 to book the date for re-stenting procedure.There was no injury to the patient during index procedure and it was completed successfully.Additional information on december 22, 2016: medtronic integrity stent was used for the re-stenting procedure on (b)(6) 2016.The site became aware of the event on december 12, 2016.The patient is good at the time of follow-up.The physician who performed the restenosis procedure was dr.(b)(6).Additional information on dec 29, 2016: the revascularization procedure took place at the same hospital, (b)(6) medical center.Dr.(b)(6) is one of the dr.(b)(6)'s partners.
Additional Manufacturer Narrative
Meeting minutes is attached.Ifu and dhr reviews are attached.
Additional Manufacturer Narrative
Final complaint report attached.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX 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: 6236121
• Report Number: 3003084171-2017-00004
• Device Sequence Number: 10991422
• Product Code: MAF
• UDI-Device Identifier: 07290107010887
• UDI-Public: 07290107010887
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: foreign,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2016

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: 01/31/2017
• Device Model Number: 3.0X17
• Device Catalogue Number: NXL30017US
• Device Lot Number: NUS00112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 02/06/2017; 04/06/2017
• 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: Required Intervention