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	Myocardial Infarction (1969)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a septal branch distally to the bifurcation.The septal branch became occluded during the procedure and was jailed off due to the main branch stent.The patient stated she had chest pain that lasted less than 1 minute during the procedure.The tryton stent was a success and the patient left the cath lab for post-op recovery.The physician felt it was best to admit the patient for observation.The patient was doing well and discharged on (b)(6) 2019.They're calling it a nstemi type 4a.What was the target lesion (mv and sb)? mv - lad, sb - diag.What was the medina classification? 1.1.1.What was percent stenosis? mv - 90%, sb - 90%.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 to low.What was the degree of tortuosity (none/low/medium/high)? none.What guide catheter (size and type) was used? 6 fr - boston scientific runway vl3 guide catheter.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? only during the post-dilation but was able to cross with another balloon size.Were multiple dilatations performed during the attempt to place the tryton stent? yes.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? no.What was the final patient outcome? mv - less than 10%, sb - less than 10%.

• 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: 8470809
• Report Number: 3007210870-2019-00001
• Device Sequence Number: 16634911
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2019

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: 08/21/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBH22B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2019
• Initial Report FDA Received Date: 04/01/2019
• 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: ASPIRIN - 81MG - QPM; CAPTOPRIL - 50MG - TID; CLOPIDOGREL - 75MG - QD; EZETIMIBE - 10MG - QD; METFORMIN - 500MG - BID; METOPROLOL SUCCINATE - 25MG - QD; NIFEDIPINE - 90 MG - QD; NITROGLYCERIN - 0.4MG - PRN; SIMVASTATIN - 20MG - QPM; TRIAMTERENE-HYDROCHLOROTHIAZIDE - 37.5-25MG - QD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Weight: 69