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

Catalog Number	T5-2525-191
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.(note: description provided here because no relevant result code is available.).
Event or Problem Description
Tryton device inserted for potential treatment of lad/diag.Tryton stent deployment was attempted, but physician was unable to cross tryton system beyond the left main artery.Removal attempt resulted in dislodgment of tryton stent from tryton delivery balloon.Stent never reached the bifurcation and came off in the lm (left main).The physician used a snare device to retrieve undeployed tryton stent and it was snared successfully.No patient injury occurred.The patient received two des and was discharged from the hospital.Operator was not trained on use of tryton.What was the medina classification? 1,1,1.What was percent stenosis? 90%.What was the degree of tortuosity (none/low/medium/high)? ns (not significant).What guide catheter (size and type) was used? 6fr.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.

• 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: 7337565
• Report Number: 3007210870-2018-00004
• Device Sequence Number: 78883
• Product Code: MAF
• UDI-Device Identifier: 00894588002125
• UDI-Public: 00894588002125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 05/24/2019
• Device Catalogue Number: T5-2525-191
• Device Lot Number: UAE25B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/14/2018
• 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
• Patient Weight: 56