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	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: target lesion was cx/lm bifurcation.Device is not approved for use in the left main in the u.S.Implanted -not returned to manufacturer.
Event or Problem Description
Attempted to deploy tryton, felt resistance when trying to get it to come out of the 6f guide catheter.Guide catheter was a 6f medtronic launcher jl3.5 shape.Could not get it to cross lesion, when attempting to pull back into guide to further pre-dilate target lesion, the tryton stent came off of the balloon.The tryton stent was crushed against profunda vessel wall and covered with another stent (intervention using dk crush technique).A subsequent tryton stent was not used.Patient survived.No death.No serious injury.Target lesion: cx/lm bifurcation.Was a guide liner used? no.Type (shape) of guide catheter was used: medtronic launcher fl3.5.Degree of calcification: none.Degree of tortuosity: none.

• 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: 6645165
• Report Number: 3007210870-2017-00004
• Device Sequence Number: 815661
• Product Code: MAF
• UDI-Device Identifier: 00894588002187
• UDI-Public: 00894588002187
• 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): 06/02/2017

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: 06/02/2017
• 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: 77 YR