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	No Code Available (3191)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received limited information that a serious adverse event had occurred on (b)(6) 2018.However, manufacturer was not aware that event may have been related to tryton device until 10/1/2018.Therefore, manufacturer considers 10/1/2018 to be the aware date.Results: trend analysis did not reveal an unfavorable trend.Examination of the lot history record showed that the lot passed all acceptance criteria.
Event or Problem Description
Patient presented with unstable angina.Catheterization showed 70-80% in-stent restenosis in the diag.Diag was a small vessel which was decided to treat medically.Relation to tryton device was described by investigator as "highly probable." patient outcome was recovered/resolved with sequelae.What was the target lesion (mv and sb)? mv - 13-mid lad, sb - 15-1st diag.What was the medina classification? 0,1,1.What was percent stenosis? mv - 90%, sb - 80%.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? none.What was the degree of tortuosity (none/low/medium/high)? none.What guide catheter (size and type) was used? 6f forte.Did the device prep normally (i.E.Maintain negative pressure)? yes.Was there any resistance/friction while inserting the balloon through the rotating hemostatic valve? none.Was there any resistance/friction while inserting the balloon through the guide catheter? none.Was predilatation performed prior to attempting to place the tryton stent? yes.Was there difficulty reaching the lesion? no.Was there difficulty crossing the lesion? no.Were multiple dilatations performed during the attempt to place the tryton stent? no.What was the final patient outcome? mv - 0%, sb - 0%.

• 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: 7957965
• Report Number: 3007210870-2018-00014
• Device Sequence Number: 11141634
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: Health Professional
• Device Expiration Date: 02/18/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBC01B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/11/2018
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 62