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

Model 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	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device problem found in analysis of production records or trend analysis.Device was not returned for evaluation; therefore, no findings were available."medium" calcification was reported.Vessels that have "moderate or severe calcification" are contraindicated in the ifu.Production records and trend analysis were reviewed with no device problem found.Because the device was implanted and not available for testing, a definitive conclusion could not be reached.Tryton medical, inc., transferred ownership of pma p150039 to poseidon medical, inc.As of september 30, 2019 and notified fda via p150039/a005.Both poseidon medical, as pma holder, and tryton medical, as manufacturer, are obligated to submit mdrs for any qualifying events with the tryton side branch stent.Therefore, this mdr was also submitted by posiedon medical, reference mdr 3016248656-2020-00002.
Event or Problem Description
The tryton stent was advanced with difficulty through a proximal stenosis, it was unable to be passed into the om for deployment.The guiding catheter was manipulated to ensure a coaxial orientation.The tryton was slowly pulled back to the guiding catheter and became dislodged from the balloon.A small diameter balloon was passed over sb wire in an attempt to capture the stent.The guiding catheter and all wires were removed with the balloon inflated in attempt to capture the stent.The tryton stent was jailed in place by another stent.The device was prepped per the ifu.An 8f medtronic ebu guiding catheter was used.At the time of this report, no adverse outcomes were noted as a result of the stent coming off the delivery balloon.What was the target lesion (mv and sb)? left cx/om.What was the medina classification? 1,1,1.What was percent mv and sb stenosis? mv-70%, sb-70%.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.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? yes.Were multiple dilatations performed during the attempt to place the tryton stent? yes.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? an attempt was made to remove, but became dislodged on this attempt.Was a subsequent tryton stent successfully deployed at the intended site? no.What was the final patient outcome? patient had successful procedure results.

• 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
• MDR Report Key: 10324413
• Report Number: 3007210870-2020-00002
• Device Sequence Number: 2698041
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 04/17/2021
• Device Model Number: T5-2530-191-US
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBD18D1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/26/2020
• 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: 78 YR
• Patient Weight: 83