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

Model Number	4.0X8
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not yet returned.Device anticipated to be returned.
Event or Problem Description
The nirxcell stent dislodged from the delivery system was reported.Nirxcell inflated to 6 atm and then a "watermelon seed" effect was noticed in which stent moved toward/into aorta.During the next picture, the stent was not seen.Entire system (guide catheter, guide wire, stent delivery system) was removed from patient.Eventually stent was found under flouro in patients sfa.The doctor was able to inflate a different balloon in the sfa to crush the nirxcell into the vessel wall, as stent was not able to be retrieved/removed.Stent had become lodged because patient had a chronic total occlusion in the sfa.Cto was fixed during vascular surgeon's procedure.The lesion was proximal rca near ostium.Patient is currently stable.The nirxcell stent system appeared normal during inspection prior to use.The system was prepped according to the ifu.The doctor did not notice any problem of stent retention on the balloon.No extensive force was used during procedure.There was no injury to patient.

• 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: 6474617
• Report Number: 3003084171-2017-00009
• Device Sequence Number: 582601
• Product Code: MAF
• UDI-Device Identifier: 07290107011006
• UDI-Public: 07290107011006
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

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: 4.0X8
• Device Catalogue Number: NXL40008US
• Device Lot Number: NUS00157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2017
• Supplement Report FDA Received Date: 06/12/2017
• 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