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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: examination of the lot history record showed that the lot passed all acceptance criteria.(note: description provided here because no relevant result code is available.).
Event or Problem Description
Index procedure (b)(6) 2017: 2 prowater 0.014" wires introduced one in the sb (diag) and one in the main branch (lad).Pre-dilatation of the side branch performed with a 2.5 x 12 emerge balloon without difficulty.Tryton 2.5 by 3.0 stent deployed in sb and mb.Pot performed with a 3.0 x 12 nc trek balloon, relocated pot balloon to the proximal tryton and attempted to wire the mb with the sb prowater gw.Had some difficulty wiring the mb with the prowater and switched to a pt graphix gw which maneuvered into the mb without difficulty.The 3.0 x 12 nc trek was then positioned in the mb trough [through] the tryton without difficulty and a pre-dilatation was performed on the mb.The pot balloon was removed and a 3.0 x 28 xience des was positioned in the mb once satisfied with the des positioning the mb prowater was withdrawn to the proximal vessel and the xience was deployed.The des delivery system was removed and the sb was attempted to be rewired with the parked prowater gw, had some difficulty rewiring the sb and switched to a pt graphix gw.Angiograms of the tryton and xience showed wide open stented area but with distal disease in both vessels.A 2.5 x 12 nc trek and a 3.0 x 12 nc emerge balloons were chosen for the final kiss inflation of the bifurcation, at this time it was noted that the balloons were becoming hung up at a point approximately 15 mm or more proximal to the proximal edge of the implanted des.It was noted at this time that a lesion that was located in the proximal vessel had become much worse and required intervention.The sb gw was removed and a des was deployed in the proximal lesion with good results.The post-dil balloon was they [then] positioned in the tryton/xience stents and used as a mini guide to direct the sb gw back into position.This balloon was then removed and the kiss balloons were attempted to be delivered into position again.The balloons still became hung up at the very proximal lesion area.With some difficulty the 3.0 x 12 nc emerge was positioned into the mb and inflated, this balloon was inflated and removed and the 2.5 x 12 nc trek was re-introduced and with difficulty again at the most proximal lesion was finally positioned in the tryton stent and was inflated.No kiss was performed.Angiograms now showed an area that appeared to be a plaque disruption/haziness at the ostium of the sb.The physician did not want to perform any more intervention on the lesion at this time and concluded the case.The 2nd intervention (b)(6) 2017: approximately 1 to 1 ½ hours after the initial procedure we were informed that the patient had been returned to the cath lab with c/o chest pain and mild st changes.Initial angiograms showed no changes from the final angiogram of the index procedure.Des were positioned and deployed in the sb distal to the tryton stent and in the mb distal to the xience.An additional stent was placed to bridge the gap area between the most proximal stent and the tryton/xience stents.Procedure was performed with no complications.The plaque disruption/haziness was still noted at the bifurcation but no kiss was performed.The physician stated that the problem was with the patient's disease and not with the stents.The 3rd intervention (b)(6) 2017: upon arriving at the facility at 7:30 am we were notified that the patient had been returned to the cath lab with a stemi and that the sb vessel was totally occluded at the ostium.Review of the films post case showed that the vessels had been rewired and re-ballooned with good results.An ivus was performed but we were unable to view those images.Patient was stable.Outcomes attributed to the adverse event (e.G., death or serious injury): mi.

• 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: 6970222
• Report Number: 3007210870-2017-00008
• Device Sequence Number: 1211328
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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 Expiration Date: 02/28/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBC01B1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERGE BALLOON (2.5 X 12); NC TREK BALLOON (3.0 X 12); PROWATER GUIDEWIRES (0.014"); PT GRAPHIX GUIDEWIRE; XIENCE DES (3.0 X 28)
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention