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

Model Number	3.5X12
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet arrived.Device not yet arrived.
Event or Problem Description
System 3.5x12 did not advance over guidewire (inside patient).Strut popped out of stent (outside patient).System was inspected prior to use and prepped according to instructions for use.No problems were noted.No excessive force was applied during preparation or insertion.When the doctor could not cross the lesion he withdraw the system to exchange guidewire, and then noticed the strut popping out.There were no difficulties withdrawing the system.The system and guiding catheter were not withdrawn as a single unit.No patient injury.
Additional Manufacturer Narrative
Dhr review, ifu review investigation report and final complaint report.
Additional Manufacturer Narrative
Final report was revised to include the corrected event classification.

• 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, jerusalem 97775 08; IS 9777508
• MDR Report Key: 6386535
• Report Number: 3003084171-2017-00007
• Device Sequence Number: 13688843
• Product Code: MAF
• UDI-Device Identifier: 07290107010948
• UDI-Public: 07290107010948
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: 3.5X12
• Device Catalogue Number: NXL35012US
• Device Lot Number: NUS00168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/09/2017; 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1