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	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.(note: description provided here because no relevant result code is available.).
Event or Problem Description
Case was done successfully; however, when physician attempted to rewire the side branch to end with a kiss, he had trouble re-wiring and decided to be done.He was pleased with the angiographic results.He does admit after the fact that he should have given more effort to kiss.Patient was thin, so sheath was left in place.The patient then had chest pain and abnormal ekg, less than an hour after the procedure.The physician requested that the patient be put back on the table.When he took pictures, there was clearly some thrombus or stenosis in the side branch within the tryton stent.Flow was still good and brisk, but he ballooned the side branch and held it up for a few minutes.After that, it looked great so that was all that was done.The physician said later that afternoon that the patient was doing well, no pain.The physician later remarked that her "lv took a hit." what was the target lesion? cx, om was the device used for a chronic total occlusion (total occlusion > 3 months)? no what was the degree of calcification (none/low/medium/high)? no what was the degree of tortuosity (none/low/medium/high)? low what guide catheter (size and type) was used? 6f, catheter shape not available 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 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? if so, how many times was it removed and was it checked visually for distortion/damage? 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: 7404056
• Report Number: 3007210870-2018-00005
• Device Sequence Number: 16417544
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

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: Physician
• Device Catalogue Number: T5-2530-191-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: BRILINTA
• Outcome Attributed to Adverse Event: Required Intervention