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

Model Number	4.0X17
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device not available for analysis.
Event or Problem Description
Initial information: tried to place stent in rca when it came off the system.They crushed the stent with a balloon and then placed an abbott vision stent to cover the crushed stent.Patient is currently in stable condition.Additional information received dec 14 2016: doctor was trying to deliver the stent to the lesion.Stent wasn't able to cross lesion and ended up coming off the delivery system.They tried to retrieve with snare but was unable to.So they crushed the stent with a balloon and then placed an abbott vision over the crushed stent.The physician was trained with the procedure.Visual inspection was performed prior to use, and the stent was handled properly and used according to the ifu.The doctor did not notice damage to the system prior to use.The vessel was calcified but was not tortures.Pre dilatation was not performed.Following the procedure the system was inspected and was found to be undamaged.The condition of the patient was stable.

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: CORONARY, STENT
• Manufacturer (Section D): MEDINOL LT.D; 8 hartom street beck tech bldg; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 6220807
• Report Number: 3003084171-2017-00001
• Device Sequence Number: 755808
• Product Code: MAF
• UDI-Device Identifier: 07290107011020
• UDI-Public: 07290107011020
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4.0X17
• Device Catalogue Number: NXL40017US
• Device Lot Number: NUS00148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 02/14/2017
• 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