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	04/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Difficult, tortuous, calcified lesion.The target lesion was cx/marginal.Stent inserted, due to calcification, unable to deliver to the anticipated site.Removal of stent delivery system and stent was not on the balloon.Stent had stripped off of the balloon shaft.Full fluoro/cine after the incident.Unable to find the stent after it stripped off.No injury to patient.What was the medina classification? 1,1,1.What was percent stenosis? >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)? high.What was the degree of tortuosity (none/low/medium/high)? medium.What guide catheter (size and type) was used? believed to be an ebu.Did the device prep normally (i.E.Maintain negative pressure)? prepped normally.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? no.Was there difficulty reaching the lesion? yes.Was there difficulty crossing the lesion? yes.Were multiple dilatations performed during the attempt to place the tryton stent? no.Was a subsequent tryton stent successfully deployed at the intended site? no.

• 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: 7521686
• Report Number: 3007210870-2018-00010
• Device Sequence Number: 1544931
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 02/15/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBB16B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1