MAUDE Adverse Event Report: TRYTON MEDICAL, INC. TRYTON SIDE BRANCH STENT; BARE METAL CORONARY STENT

Catalog Number	T5-2530-191-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.(note: description provided here because no relevant result code is available).Device implanted (not returned to manufacturer).
Event or Problem Description
The patient had a tryton stent placed on (b)(6).The patient was brought back emergently to the ccl on (b)(6) and those arteries stented were ballooned open.An oct imaging run was performed at that time.The patient was brought back a second time, also emergently, on (b)(6).Ballooning was performed at that time as well.The patient was discharged on (b)(6).The patient's issue was resolved by addressing the vessel occlusion due to thrombosis.Ptca was used to open occluded vessels.The oct showed calcification in the main branch distal to the bifurcation.Physician supposed it was not post dilated enough thus causing the thrombosis.This patient has a history of stent thrombosis in other vessels, during a prior coronary intervention.

• Brand Name: TRYTON SIDE BRANCH STENT
• Common Device Name: BARE METAL CORONARY STENT
• Manufacturer (Section D): TRYTON MEDICAL, INC.; 1000 park forty plaza; suite 325; durham NC 27713
• MDR Report Key: 6772221
• Report Number: 3007210870-2017-00006
• Device Sequence Number: 10944050
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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: 02/15/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBB16B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/07/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 89