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

Model Number	3.0X33 MM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Event occurred during post market clinical study, (b)(6).(b)(4).Date of index procedure: (b)(6) 2016.Time to event (days): 0 days.This report is for subject (b)(4), an (b)(6) female participating in the (b)(6) study.The study is a "prospective, post-marketing, nonrandomized, multi-center, single-arm clinical study.This study is designed to collect and analyze additional information about the safety and effectiveness of the nirxcell stent system in the treatment of de novo stenotic lesions in native coronary arteries in the us population".The subject's relevant medical history includes previous percutaneous coronary intervention in 2012, family history of premature coronary artery, atrial fibrillation, diabetes mellitus, hypertension and hypercholesterolemia.The subject's concomitant medications include: heparin, nitroglycerin, aspirin and clopidogrel.On (b)(6) 2016, the subject underwent the index procedure with unsuccessful deployment nirxcell stent in the middle rca.After pre-dilatation the study stent was unable to cross the target lesion and while attempting to pull it back into the guide, the study stent did not pull back and it was dislodged from the delivery system.The delivery system was removed and a second balloon was inserted with stent.In the radial artery, the study stent did not go back through the sheath and started to unravel.Stent embolization occurred; therefore it was deployed in the radial artery.Three non-study stents (2.5x26 mm, 2.5x14 mm, 2.5x14 mm) were implanted in the right coronary artery with a result of 0% residual stenosis with a restoration of timi 3 flow.The case was resolved and the patient recovered.In the investigator's opinion the event of device embolization was considered moderate in intensity, anticipated, related to the study device and unrelated to the study procedure.The sponsor considers the event of device embolization anticipated, related to the study device and possibly related to the index procedure.The above is a summary of the information received at medinol from: (b)(6).
Additional Manufacturer Narrative
Device not available for assessment.Waiting for angiograph to arrive.
Additional Manufacturer Narrative
Angiographic evaluation performed.No additional information.(b)(4).

• Brand Name: NIRXCELL COCR CORONARY STENT ON RX SYSTEM
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): MEDINOL LT.D; 8 hartom street beck tech bdg; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 5456019
• Report Number: 3003084171-2016-00001
• Device Sequence Number: 13552340
• Product Code: MAF
• UDI-Device Identifier: 07290107010924
• UDI-Public: 07290107010924
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2016

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: Physician
• Device Expiration Date: 10/13/2017
• Device Model Number: 3.0X33 MM
• Device Catalogue Number: NXL30033US
• Device Lot Number: NUS00229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2016
• Supplement Report FDA Received Date: 05/02/2016; 06/05/2016
• 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: ASPIRIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 71