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

Catalog Number	T5-2530-191-US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: production records and trend analysis were reviewed with no device problem found.Because device has not been returned, a definitive conclusion by tryton could not be reached.Conclusion: medium calcification reported."vessels that have moderate to severe calcification" are contraindicated in the instructions for use.
Event or Problem Description
Tryton stent [was] to be placed in the lad, 2nd diag.[tryton] stent would not advance after pre dil and removed.[after] another pre-dil, tryton would not advance and stent attempted to be removed and dislodged from the balloon.The doctor snared the stent with 0.014 guidewire and pulled the stent out of the artery, and partially into the guide catheter.Catheter retracted to distal forearm.Stent was left in vessel and a vascular surgeon came and decided to leave the stent in place and see how the patient does.What was the target lesion (mv and sb)? lad and 2nd diagonal.What was the medina classification? 1,1,1.What was percent mv and sb stenosis? 80-80.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? medium.What was the degree of tortuosity (none/low/medium/high)? medium.What guide catheter (size and type) was used? 6f cordis xb 3.5.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? yes, possible kink in the guide catheter.Was predilatation performed prior to attempting to place the tryton stent? yes.Was there difficulty reaching the lesion? yes, did not get to the lesion.Was there difficulty crossing the lesion? did not cross.Were multiple dilatations performed during the attempt to place the tryton stent? yes.One additional dilatation after initial dilatation and removal of tryton.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? yes, tryton stent was removed one time to allow a second dilatation.Yes, stent was checked visually for distortion/damage.If multiple tryton devices were used during the procedure, include device sizes used (ex.2.5/3.5, 2.5/3.0, etc.).Only one tryton device was used.Was a subsequent tryton stent successfully deployed at the intended site? no, a second tryton was not used.What was the final patient outcome? patient was stable and went back the holding area.The [doctor] was to bring the patient back later to do the pci.
Event or Problem Description
The following additional details were received regarding this stent dislodgement event.In the initial procedure, there was resistance/friction while inserting the balloon through the 6f vista brite tip xb 3 guide catheter.This guide catheter is not a tryton device; it is a cordis device and cordis is aware of the reported issue.The guide catheter kinked just distal to the end of the sheath.At the time of the initial procedure, the vascular surgeon decided to leave the dislodged stent in place.Subsequently, the patient came back to have the pci completed and the patient is doing well.

• Brand Name: TRYTON SIDE BRANCH STENT
• Common Device Name: CORONARY BARE METAL STENT
• Manufacturer (Section D): TRYTON MEDICAL, INC.; 1000 park forty plaza; suite 325; durham NC 27713
• MDR Report Key: 9115803
• Report Number: 3007210870-2019-00007
• Device Sequence Number: 11224710
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 03/18/2021
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBC19D1000
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: 81 YR