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	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device problem found in analysis of production records or trend analysis.Device was not returned for evaluation (implanted), therefore no findings were available.Production records and trend analysis were reviewed with no device problem found.Because the device was implanted and, therefore not available for testing, a definitive conclusion could not be reached.
Event or Problem Description
Patient presented with chest pain the morning of (b)(6) 2019.It was reported that the side branch (1st diag) had 90% in-stent restenosis.Resolved after des placement at distal edge of previously placed stent and in the proximal/ostial 1st diagonal.A 2.0 x 8 onyx stent and a 2.0 x 12 onyx stent were used to treat the lesions.After pci, 1st diagonal showed 0% stenosis.Patient experienced bradycardia and was hypotensive after pci and transferred to icu.Patient recovered and was discharged on (b)(6) 2019.Additional notes: on (b)(6) 2018: tryton was initially implanted in lad/diag and xience stent in mv.On (b)(6) 2018: patient was treated for restenosis 237 days post index procedure.It was reported that the side branch had 70-80% in-stent restenosis in the diagonal.The decision was made to treat the restenosis medically.No changes in medication were noted.Reference manufacturer report no.3007210870-2018-00014.

• 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: 8533145
• Report Number: 3007210870-2019-00002
• Device Sequence Number: 1612345
• 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): 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/02/2019
• Initial Report FDA Received Date: 04/19/2019
• 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: CORONARY STENTS PLACED IN 2011, 2013, 2018.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 62