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

Catalog Number	T5-3035-151-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	03/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Restenosis was initially reported for this case.After discussion with the patient's interventionalist, it was determined that the patient had thrombosis that was detected approximately 6 months after the index procedure where the tryton and other stents were implanted.Device was implanted but implantation date is unknown.Results: although the exact lot number is unknown, a tryton 3.0/3.5 mm stent was implanted.Five possible lots were identified.Examination of the lot history records showed that the five lots passed all acceptance criteria.(note: description provided here because no relevant result code is available).Conclusion: tryton device was used in the left main which is considered off-label.High degree of calcification reported.The current ifu includes the following contraindication: "vessels that have moderate to severe calcification." also, multiple long des (26mm, 38mm, plus others without stent length stated) were implanted with overlapping of the stents.It was reported that the patient had "disease extending into large distal lcx." the current ifu includes the following contraindication: "an untreated significant (>50%) stenosis proximal or distal to the main branch or side branch target lesion." manufacturer's narrative: of note, it is unclear if the patient was dapt compliant.In light of the angiographic finding and the timing, it would be appropriate to consider this a definite late thrombosis without findings that indicated structural problems with the tryton stent.
Event or Problem Description
A (b)(6) year old patient had undergone elective pci-stent of a complex lmca lesion in which the patient received a tryton stent.Initial case was significant for placement of tryton into the lmca with the side branch portion into the lcx after which a standard des was placed in the lmca extending into the lad.To address additional disease in the lcx a long des was placed bringing it back into the lmca utilizing 'tap' technique and finishing with a final simultaneous kissing inflations with good angiographic result.The patient was discharged without apparent complications on dapt.More than 5 months later, the patient presented to an outside hospital in extremis.Brief angiography was performed which demonstrated thrombotic occlusion of the lad and lcx.The patient was emergently transferred to the hospital and passed soon after.Additional details on tryton stent implantation procedure: - cath at outside hospital: 90% medina 1,1,1 at left main, heavily calcified, with disease extending into large distal lcx.Rca has disease but is nondominant.Lvef 40% on cineangiography.- ninety nine degree angle between lad and lcx.- tryton (3.0/3.5) placed after poba of both ostia.- post dilatation of lm portion of tryton.- des placed in lm/lad.- poba of lcx.- pre- and post-dilatation of jailed tryton.- a 38mm des placed in lad.- a 26mm des to finish tap at lm bifurcation: tryton in first 5mm of lcx.- des deployed in lcx.- kissing performed.- patient did well without angina or chf at follow-up.

• 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: 7445183
• Report Number: 3007210870-2018-00007
• Device Sequence Number: 16573740
• Product Code: MAF
• UDI-Device Identifier: 00894588002187
• UDI-Public: 00894588002187
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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?: No
• Operator of Device: Physician
• Device Catalogue Number: T5-3035-151-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: Death
• Patient Age: 67 YR