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

Catalog Number	T5-2535-191-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.Trend analysis did not reveal an unfavorable trend.(note: description provided here because no relevant result code is available.).
Event or Problem Description
Nstemi/unstable angina due to restenosis of a stent placed distal to original target lesion.This particular stent is not part of the tryton side branch stent or the des within the tryton.The stent that restenosed was a bail out stent placed during index procedure far distal to the original lesion.The bailout stent during the index procedure was due to distal dissection involving the main branch.Lcx (culprit vessel), 95% stenosis treated with elunir stent and om with 75% stenosis.Per physician, om may have had contributed to the event but not the culprit vessel.An incidental finding was restenosis of the side branch portion of the tryton.A decision was made to place a short des in this location.It is unlikely that this contributed to presentation of nstemi.In other words, this was a non-culprit site.

• 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: 7870855
• Report Number: 3007210870-2018-00012
• Device Sequence Number: 1835492
• Product Code: MAF
• UDI-Device Identifier: 00894588002149
• UDI-Public: 00894588002149
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: 02/23/2019
• Device Catalogue Number: T5-2535-191-US
• Device Lot Number: UCB24B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• 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: 44 YR