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

Model Number T5-2530-191-US

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Code Available (3191)

Event Date 01/03/2020

Event Type  Death  

Manufacturer Narrative

Patient was 82 or 83 years old.No code available.The patient had a bypass (lima) due to the considered potential risk of the retained piece of wire becoming thrombosed due to natural body processes and thus increasing the risk of myocardial infarction and subsequent necrosis.Event categorized as loss of guidewire position and unable to withdraw guidewire.Results: no device problem found in analysis of production records or trend analysis.Device was not returned for evaluation; therefore, no findings were available.Conclusions: "medium" calcification was reported.Vessels that have "moderate to severe calcification" are contraindicated in the ifu.The medium calcification is unlikely to 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 Description

The physician successfully deployed the 2.5/3.0mm x 19mm tryton coronary stent & 3.0x20 mm elunir stents into the diagonal (tryton) and lad (elunir).There was no reported patient injury.The physician was in the process of repositioning the non-cordis.014 wire, when the distal end of the wire caught onto the proximal strut of the stent.The physician tried to remove the wire, but it wouldn't come loose.They proceeded to use a balloon and dotter the wire hoping it would come loose, but that didn't work.They then proceeded to use a snare to retrieve the wire, but the snare became stuck.They proceeded to remove the guide, snare, and wire, after the snare became caught.There was approximately 15mm of the wire still wrapped around the strut.The patient was stable though out the procedure.The physician thought it would be best to have the patient undergo a bypass (lima), because the wire will thrombus in the future.It was reported that the patient was stable after the surgery.The target lesion was left anterior descending (lad) and second diagonal.The medina classification was 1,1,1.The percent of mv (main vessel) and sb (side branch) stenosis was 60-80%.The device was not used for a chronic total occlusion (cto).The degree of calcification/tortuosity was medium.The guide catheter size was 7fr.The device was prepped normally and was able to maintain negative pressure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter.The predilatation was performed prior to attempting to place the tryton stent.The physician predilated the diagonal and main branch.There was no difficulty reaching the lesion.The tryton sailed into the diagonal with no resistance.There was only one dilatation performed during the attempt to place the tryton stent.The tryton stent was not removed between dilatations.Only one tryton device was attempted during the procedure.The other additional procedural details were requested but were unknown.Procedural complication in this case refers to the guidewire becoming trapped on an implanted stent and the tip being separated and left behind in the patient's coronary vasculature, thus requiring surgery to bypass the vessel.The surgery was decided upon due to the considered potential risk of the retained piece of wire becoming thrombosed due to natural body processes and thus increasing the risk of myocardial infarction and subsequent necrosis.

Manufacturer Narrative

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 poseidon medical on april 9, 2020, reference mdr 3016248656-2020-00001.Per 21 cfr 803.56, an mdr supplement must be submitted to fda within 30 calendar days of the date that the new information was received.This mdr supplement is being submitted more than 30 calendar days after the poseidon mdr number was obtained (april 9, 2020), due to issues with tryton's esg account.

• Brand Name: TRYTON SIDE BRANCH STENT
• Type of Device: BARE METAL CORONARY STENT
• Manufacturer (Section D): TRYTON MEDICAL, INC.; 1000 park forty plaza; suite 325; durham NC 27713
• MDR Report Key: 9670392
• MDR Text Key: 191608451
• Report Number: 3007210870-2020-00001
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (y/n): N
• PMA/PMN Number: P150039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: T5-2530-191-US
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBC19D1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention