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

Model Number	2.75X20
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	08/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
Initial information: an email was received from dr.(b)(6) stating "we recently had 2 acute stent thrombosis with medinol.I called (b)(6) md 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." additional information was received from medinol usa on december 12, 2016: it was confirmed that the complaint was about 2 patients and therefore medinol decided to open two separate complaints with the current information.Additional information was received from medinol usa on december 20, 2016: it was confirmed that the complaint was about 3 patients and therefore medinol opened the third complaint.Additional information was received from medinol usa on december 21, 2016: "on (b)(6) 2016, a male came in (b)(6) with an occluded mid rca.He received a nirxcell 2.75x20 (no lot available) that was pre-dilated with a 2.5x20mm trek and post-dilated with 3.0x20mm trek.He was sent home on brilinta with 1 month free script, he called the office after first month to say that he could not afford to purchase it the next month.He was switched to plavix.On (b)(6) 2016, he represented to the e.R.With unstable angina.Dr.(b)(6) took him to the ccl where it was discovered he had a distal edge stenosis of the stent and that he was a plavix intermediate responder.Dr.(b)(6) and i agreed that the lesion appeared to be edge restenosis not a st." there was no tracking difficulty, no problem with crossing the lesion, no problem inflating the stent, no problem with stent retention on the balloon.Neither there was no kink in the delivery system.The 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.

• 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, jerusalem 97775 08; IS 9777508
• MDR Report Key: 6220804
• Report Number: 3003084171-2017-00002
• Device Sequence Number: 415456
• Product Code: MAF
• UDI-Device Identifier: 07290107010825
• UDI-Public: 07290107010825
• 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?: No
• Operator of Device: No Information
• Device Model Number: 2.75X20
• Device Catalogue Number: NXL27520US
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BRILINTA; PLAVIX
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention