MAUDE Adverse Event Report: TRYTON MEDICAL, INC. TRYTON SIDE BRANCH STENT; BARE METAL CORONARY STENT

Catalog Number	T5-3035-151-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	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted (not returned to manufacturer).
Event or Problem Description
The tryton side branch stent dislodged from the balloon undeployed in the coronary artery.The physician pre-dilated with a 2.0 x 12 mm balloon on the diagonal wire and was unable to successfully advance the tryton stent system.The stent system was then removed and a 2.5 x 12 mm nc balloon was used to predilate the lesion.A second wire was then advanced down the diagonal to help with tracking of the tryton system after the nc balloon was removed.Again, tryton did not track down the vessel and the stent system was removed.Upon removal, the fellow noticed that the tryton stent was not on the balloon.Under fluoroscopy, it was difficult to visualize the undeployed stent.The physician decided to advance a small 1.5 mm balloon on the wire to see if it was possible to capture the stent and pull it back into the guide catheter.While this attempt did work in capturing the stent, the stent edge was caught on the guiding catheter and it could not be retrieved.A 2.5 mm balloon was advanced, which pushed the stent down the lad/diagonal wire and the stent was deployed.The physician then took a des and deployed it inside the tryton stent without complication.In the end, the outcome was good for the patient.

• 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: 6561749
• Report Number: 3007210870-2017-00001
• Device Sequence Number: 19103282
• Product Code: MAF
• UDI-Device Identifier: 00894588002187
• UDI-Public: 00894588002187
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/28/2017

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: 02/22/2019
• Device Catalogue Number: T5-3035-151-US
• Device Lot Number: UFB23B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/11/2017
• 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