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

Catalog Number	T5-2530-191-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	04/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to deliver a 2.5 x 3.0 mm tryton stent from a radial approach (using a 6 french guiding catheter) to an lad/circ stenosis, the stent came off the balloon.The guide catheter was not properly seated at the ostium of the left main and did not provide adequate support during tracking of the tryton stent (the catheter was not engaged with the left main).Subsequently, while tracking the tryton stent delivery system, the stent exited the guide within the aorta and could not advance within the left main due to the lack of guide support.While attempting the withdraw the tryton, the stent became dislodged.The tryton stent was found in the right profunda and successfully snared and removed.Using the same guiding catheter, and femoral access, the physician was able to successfully implant a new tryton stent within the target lesion without difficulty.The physician noted that the guiding catheter shape was designed for femoral access and as a result, it was appropriately engaged within the left main.The case was part of the tryton post-approval study.There was no patient injury.What was the medina classification? 1-1-1.What was percent stenosis? 70% - 80%.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? none/low.What was the degree of tortuosity (none/low/medium/high)? none/low.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.Was there difficulty reaching the lesion? yes.Was there difficulty crossing the lesion? some.Were multiple dilatations performed during the attempt to place the tryton stent? yes.Was the tryton stent removed between dilatations? (yes).If so, how many times was it removed.(twice) and was it checked visually for distortion/damage? (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: 7479383
• Report Number: 3007210870-2018-00008
• Device Sequence Number: 10846277
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/04/2018

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: 04/23/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBD24B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/02/2018
• 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: 70 YR
• Patient Weight: 113