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

Model Number	2.5X12
Medical Device Problem Codes	Break (1069); Kinked (1339); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Codes	Aneurysm (1708); Myocardial Infarction (1969); Stenosis (2263)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report, complaint final report, ifu review and dhr review attached.
Event or Problem Description
Reportability was decided on march 28, 2017 after re-reviewing the event file.Stemi patient that also had an abdominal aortic aneurysm with multiple lesions in lad and om1; physician and staff in the case noted extremely tortuous anatomy especially at the site of the untreated lesion, mid om1; there was an extremely tight tortuous loop in the om1 where the nirxcell 2.5 x 12 was unable to track to despite the use of a guideliner, multiple pre dilations, and deployment of a 2.5 x 17 in the proximal om1; physician applied enough push on the sds of the nirxcell 2.5 x 12 that the catheter kinked and eventually snapped; the patient was not harmed during the procedure; ultimately no stents were able to track to this lesion in the mid om1; the physician was able to successfully treat a tight lesion in the lad with a 3.0 x 17 nirxcell and a different lesion in the proximal om1 with a 2.5 x 17 nirxcell.The device was used in acute mi.De novo, stenosis 95%, no bifurcation, no pre existing clot.There was predilation with pressure 12.Stent dilation pressure was 18.There was post dilation with pressure 20.Timi flow pre procedure was 2 and timi flow post procedure was 3.Two stents were deployed during procedure.Location of lesion was mid omi1, the event was related to delivery system (other than balloon).There was tracking difficulty because of an extremely tight tortuous loop in the om1 where the nirxcell 2.5x12 was unable to track.There was no problem inflating the stent, there was no problem with stent retention.The procedure was not completed.Additional information on march 30, 2017 revealed that the catheter broke at the site of the kink which occurred outside of the body during procedure.There was no difficulty removing the system.

• 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: 6474624
• Report Number: 3003084171-2017-00008
• Device Sequence Number: 18915452
• Product Code: MAF
• UDI-Device Identifier: 07290107010764
• UDI-Public: 07290107010764
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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: 05/30/2018
• Device Model Number: 2.5X12
• Device Catalogue Number: NXL25012US
• Device Lot Number: NUS00237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 04/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1