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

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	04/17/2019
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 to severe calcification" are contraindicated in the ifu.The medium level of calcification may have contributed to the reported issue.Chronic total occlusion (cto) of the main branch (rca) was reported."vessels that are totally occluded." are contraindicated in the ifu.The totally occluded vessel may have contributed to the reported issue.Production records and trend analysis were reviewed with no device problem found.Because the device was not available for testing, a definitive conclusion could not be reached.
Event or Problem Description
Upon attempting to insert the [tryton] stent it became dislodged from the balloon and settled into the patient's right coronary artery.Attempts were made to snare the stent but were unsuccessful so the physician crushed it with another stent.There was no patient injury.What was the target lesion (mv and sb)? rca and plv [posterior left ventricular artery] what was the medina classification? 1,1,1.What was percent mv and sb stenosis? mb 100% cto, sb 60%.Was the device used for a chronic total occlusion (total occlusion > 3 months)? main branch cto.Sb no cto.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 ebu.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, once the stent exited the guide there was resistance at the rca ostium.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? device did not reach lesion.Were multiple dilatations performed during the attempt to place the tryton stent? no.

• Brand Name: TRYTON SIDE BRANCH STENT
• Common Device Name: BARE METAL CORONARY ARTERY
• Manufacturer (Section D): TRYTON MEDICAL, INC.; 1000 park forty plaza; suite 325; durham NC 27713
• MDR Report Key: 8575096
• Report Number: 3007210870-2019-00003
• Device Sequence Number: 16653800
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 11/20/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: :UBK21B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/02/2019
• 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