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 Codes	Myocardial Infarction (1969); Vascular Dissection (3160)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.Conclusions: device was implanted in patient, so not accessible for testing.
Event or Problem Description
Post procedure, the patient reported chest pain and was tested to have elevated cardiac enzyme biomarkers (troponin, ck, and ckmb).This patient also had a dissection (distal tryton stent edge of diagonal) during the procedure.As a result, an additional stent was placed to cover this lesion.The doctor also noted that the mb disease appeared to be approximately 30 mm.Two separate stents were placed thereafter in the mb to treat this disease.The final patient outcome was recovered/resolved.What was the target lesion? mid-lad / 1st diag.What was the medina classification? 1.1.1.What was percent stenosis? 90% lad, 60% diagonal.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? low.What was the degree of tortuosity (none/low/medium/high)? none.What was the angle of the bifurcation? 45.What guide catheter (size and type) was used? 7fr xb guidecath.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? no.Was there any resistance/friction while inserting the balloon through the guide catheter? no.Was predilatation of the mv and sb 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.Was the tryton stent removed between dilatations? no.

• 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: 7787226
• Report Number: 3007210870-2018-00011
• Device Sequence Number: 11275028
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 04/23/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBD24B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/15/2018
• 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
• Patient Age: 52 YR
• Patient Weight: 79