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	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted (not returned to manufacturer).
Event or Problem Description
The tryton stent was properly placed after a distal stent in the main vessel (distal pda) was placed.Vessels were wired and predilated.Tryton was placed properly.Wire placement was lost and the two physicians were unable to rewire main vessel.After three hours in the case and 300 cc of contrast, the case was rescheduled for des placement at a later date.The main vessel des was successfully implanted in the patient on (b)(6) 2017 (note: the original procedure date when the tryton stent was implanted was (b)(6) 2017).Final outcome was good/successful.Degree of tortuosity: rca was moderate to severe.Additional details: tryton passed lesion easy, difficulty placing des.Distance between distal stent and tryton: approximately 30 mm.The distal stent did not contribute to inability to continue case.When attempting to place the des, they lost wire placement and were unable to re-wire.
Additional Manufacturer Narrative
The following information was received after the original mdr submission (5/31/2017) and is now being provided in this supplement: patient identifier, patient sex, describe event/problem (additional details provided), concomitant medical products and therapy dates.The following missing information was requested via email, but not received: patient age or date of birth, patient weight, other relevant patient history including pre-existing medical conditions.
Event or Problem Description
Additional details: medina classification: 1,1,1.Percent stenosis: 90%.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no degree of calcification: medium.

• 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: 6600722
• Report Number: 3007210870-2017-00002
• Device Sequence Number: 943864
• 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,Followup
• Report Date (Section B): 05/18/2017

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: UFB23B100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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: Hospitalization; Required Intervention