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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted (not returned to manufacturer).
Event or Problem Description
The tryton side branch stent came off of the balloon catheter while attempting to remove from the patient through guide catheter.The physician did experience resistance when trying to cross the lesion prior to pulling the tryton back towards the guide.Attempt to cross the lesion was unsuccessful and upon removal of stent delivery system, it was noted that the stent was no longer on the balloon.Stent was visualized under flouro in circumflex artery.Vessel was rewired and a des was advanced to site of the tryton stent, inflated thus crushing the tryton stent into the vessel wall.No adverse patient event took place and case was completed successfully once tryton stent was crushed.Other details: a guideliner was not used in this procedure.The target vessel was circumflex, om bifurcation.This was the physician's 7th tryton case.Degree of calcification: high.Was the device used for a chronic total occlusion (total occlusion > 3 months)? 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: 6645118
• Report Number: 3007210870-2017-00003
• Device Sequence Number: 1305676
• Product Code: MAF
• UDI-Device Identifier: 00894588002149
• UDI-Public: 00894588002149
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: T5-2535-191-US
• Device Lot Number: UCC03B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/15/2017
• 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: Required Intervention
• Patient Age: 58 YR