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 Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two tryton devices were used.Information for second tryton device: catalogue number: t5-2525-191-us, manufacture date: 08/24/2017, unique device identifier (udi) number: (b)(4), lot number: uah24b1000, expiration date: 08/23/2019.Production records and trend analysis were reviewed with no device problem found.Because the device was not returned and therefore, not available for testing, a definitive conclusion by tryton could not be reached.However, both doctors and the customer sales representative involved in this case concluded that tryton device was not at fault.The second tryton was pulled off the balloon by the 2nd diagonal stent.Furthermore, lifted struts on the 2nd diagonal stent caused it to become entangled with the second tryton stent and thus be pulled from its original location.It is concluded that the resulting lad dissection was the result of the 2nd diagonal stent struts being lifted and not the result of any issue with the tryton stent/device.
Event or Problem Description
An attempt was made to treat the lad/3rd diagonal lesion using two tryton stents.The first tryton stent (2.5x3.0) was unable to cross the lesion due to, what was later determined to be, interference from a stent that had been previously implanted at the 2nd diagonal and which had lifted struts.The first tryton was successfully withdrawn without being expanded.The 3rd diagonal lesion was dilated again.This was followed with attempting to treat the lesion with a second tryton device (2.5x2.5).The second tryton device was also unable to cross the lesion.When trying to withdraw the second tryton device, it became dislodged and came to rest in the right common femoral artery.Left femoral access was obtained and the stent was retrieved using a snare.The removed second tryton device was examined and found to have attached to it the previously implanted 2nd diagonal stent.The following angiogram showed a dissection in the lad which was subsequently treated with stenting.

• 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: 8770092
• Report Number: 3007210870-2019-00004
• Device Sequence Number: 1690620
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/08/2019
• 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