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

Model Number	3.0X20
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	10/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available for evaluation.
Event or Problem Description
Description: i received an email from dr.(b)(6) that stating "we recently had 2 acute stent thrombosis with medinol.I called (b)(6) to discuss as he is the primary user of nirxcell at this account.He said he was going to look the patients up next week and let me know the details." this complaint was initially received and filed as (b)(4) on (b)(6) 2016.Late evening on (b)(6) 2016 medinol received email from medinol usa confirming that this complaint involved two different patients.As a results medinol opens this complaint (b)(4) for the second incident.Additional information received dec 20 2016: on (b)(6) 2016 a female with non stemi angina was scheduled for a heart cath with dr.(b)(6).It was discovered she had a native circumflex lesion that was treated with a 3.0x20 nirxcell (no lot # available).On (b)(6) 2016 she presented to the er with back and chest pain and dr.(b)(6) discovered a proximal edge stenosis of the nirxcell in which he placed a xience stent which overlapped the nirxcell.Dr.(b)(6), dr.(b)(6) and myself all agreed it was edge restenosis not an st.Complaint classification was changed from stent thrombosis to in-stent restenosis.
Additional Manufacturer Narrative
Meeting minutes is attached.Ifu review is attached.Final complaint report is attached.Device not available for evaluation.

• Brand Name: NIRXCELL COCR CORONARY STENT OM 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: 6220806
• Report Number: 3003084171-2017-00003
• Device Sequence Number: 876285
• Product Code: MAF
• UDI-Device Identifier: 07290107010894
• UDI-Public: 07290107010894
• 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,foreig
• 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: 3.0X20
• Device Catalogue Number: NXL30020US
• 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: 02/06/2017
• 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