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	Foreign Body In Patient (2687)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Methods: delivery system but not stent returned for evaluation.Results: no material of manufacturing defects were found during review of manufacturing records or during evaluation of the returned device (minus stent).No findings available for stent since it was not returned.Trend analysis does not show an unfavorable trend requiring reporting per fda requirements 21 cfr 803.3(2) and 803.53(a).Conclusion: the doctor reported that the vessel to be stented (circumflex artery) was highly tortuous so much so that he was unable to get the guide seated coaxially.After he was unable to deliver the tryton in the target lesion, the stent hung up on the lower edge of the guide when he was attempting to withdraw the stent catheter resulting in the tryton becoming dislodged from the stent balloon.A follow up foreign body removal procedure was performed and the tryton was successfully retrieved." ifu contraindications states: "target lesions that have excessive tortuosity [are] unsuitable for stent delivery and deployment.' ifu instructions for use of the tryton states, ".If removal of the entire system with the guiding catheter as a single unit is not clinically feasible.Ensure the guiding catheter is: coaxial with the tryton side branch stent/stent delivery system.Failure to follow these steps.Can result in loss or damage to the stent." high calcification was reported."vessels that have moderate to severe calcification" are contraindicated in the ifu.The returned device had a previously inflated balloon.Review of the reported issue and evaluation of the returned device were unable to determine at what point in time that the balloon inflation occurred.Inflating and deflating the balloon prematurely will result in the stent separating from the balloon and dislodging.The ifu warnings lists the following risk associated pci, "stent dislodgement from balloon surface during deployment and/or dislodgment from the target site post-deployment can occur." the following may have contributed to the report of stent dislodgment: high calcification of lesion, and/or.Highly tortuous circumflex artery, and/or.The guiding catheter not being coaxial with the tryton stent/stent delivery system, and/or premature inflation/deflation of the balloon.
Event or Problem Description
Attempting to cross and stent a tortuous circ over a runthrough wire, through a 6fr xblad via radial access.Tryton would not cross even after aggressive predil[ation].While removing tryton the stent became dislodged from the balloon catheter.Physician then lost wire access and the dislodged stent lodged in the thoracic branch.Physician went in two days later and was successful in snaring and removing the dislodged tryton.There was no injury.The bifurcation lesion was treated via standard provisional approach.A follow-up discussion with the physician confirmed that the circumflex artery that was to be stented with the tryton was highly tortuous, so much so that he was unable to get the guide seated coaxially.After he was unable to deliver the tryton in the target lesion, the stent hung up on the lower edge of the guide when he was attempting to withdraw the stent catheter resulting in the tryton becoming dislodged from the stent balloon.A follow up foreign body removal procedure was performed and the tryton was successfully retrieved.There was no patient injury.What was the target lesion (mv and sb)? lma / cir 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 cto what was the degree of calcification (none/low/ medium/high)? high what was the degree of tortuosity (none/low/medium/high)? high what guide catheter (size and type) was used? 6fr xblad did the device prep normally (i.E.Maintain negative pressure)? normal prep was there any resistance/friction while inserting the balloon through the rotating hemostatic valve? none noted.Was there any resistance/friction while inserting the balloon through the guide catheter? none noted.Was predilatation performed prior to attempting to place the tryton stent? yes, multiple predilatations performed.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? yes, during predil was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? no if multiple tryton devices were used during the procedure, include device sizes used (ex.2.5/3.5, 2.5/3.0, etc.).Not applicable; only one tryton device attempted.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: 8056886
• Report Number: 3007210870-2018-00015
• Device Sequence Number: 1624960
• Product Code: MAF
• UDI-Device Identifier: 00894588002187
• UDI-Public: 00894588002187
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/15/2018

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: Health Professional
• Device Expiration Date: 07/24/2019
• Device Catalogue Number: T5-3035-151-US
• Device Lot Number: UFG25B1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/09/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 53