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

Model Number	3.5X28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Stenosis (2263)
Date of Event	02/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet returned.
Event or Problem Description
The stent came off the stent delivery balloon in the guide catheter as the doctor was retrieving it from the ostial rca because it wouldn't cross.When he pulled the sds all the way out he noticed the stent wasn't on the balloon.He then used fluoro and determined the stent was in the guide catheter at which time he had to pull the guide and wire out of the patient.De novo, 85% stenosis, no bifurcation, no pre existing clot.There was no pre dilation.Lesion calcification: medium.Vessel calcification: low.Vessel was not tortuous.The procedure was completed with another product.There was no injury to the patient.Additional information: the system was inspected prior to use and appeared normal.The system was stored, handled and prepped according to the ifu.The guiding catheter and stent delivery system were not removed as a single unit.The delivery system was removed by retracting it into the guiding catheter.
Additional Manufacturer Narrative
Ifu review, device analysis and final report.

• 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: 6474625
• Report Number: 3003084171-2017-00010
• Device Sequence Number: 18996386
• Product Code: MAF
• UDI-Device Identifier: 07290107010986
• UDI-Public: 07290107010986
• 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,Followup,Followup
• Report Date (Section B): 03/22/2017

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: 08/15/2018
• Device Model Number: 3.5X28
• Device Catalogue Number: NXL35028US
• Device Lot Number: NUS00248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/09/2017
• Supplement Report FDA Received Date: 05/10/2017; 06/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1