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 Code	Myocardial Infarction (1969)
Date of Event	04/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tryton aware date: (b)(6) 2019 - initial notification of event from the site.The event was described by site as "unlikely related" to tryton device.Therefore, a complaint was not generated at this time.(b)(6) 2019 - tryton received notification of the adjudication by the clinical events committee (cec) for the post approval study that the event was "probably related" to the tryton device.As a result, a complaint was generated.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.
Event or Problem Description
The continuation of the lcx closed after deployment of the tryton stent from proximal lcx into om1 and dilation with a short 4.0mm balloon in the proximal portion.The patient experienced significant chest pain but remained stable from rhythm and hemodynamic standpoints.Multiple wires were used to reaccess the and eventually open the lcx continuation.The onyx stent was then deployed from proximal to mid lcx.A side cell of the stent was ballooned to "unjail" the om1 with kissing balloon inflation.A good angiographic result was achieved.Ck-mb [of 51.7 is] greater than 3x the upper normal limit [of 7.2].This is defined as a peri-procedural mi.What was the target lesion (mv and sb)? mv - 18.5-mid circ no 5, sb - 20-1st ob marg.What was the medina classification? 1.1.1.What was percent stenosis? mv - 80%, sb - 80%.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? none.What was the degree of tortuosity (none/low/medium/high)? low.What guide catheter (size and type) was used? 6fr ebu 4.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? no.Was predilatation performed prior to attempting to place the tryton stent? yes.Was there difficulty reaching the lesion? no.Was there difficulty crossing the lesion? no.Were multiple dilatations performed during the attempt to place the tryton stent? no.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? n/a.If multiple tryton devices were used during the procedure, include device sizes used (ex.2.5/3.5, 2.5/3.0, etc.).N/a.Was a subsequent tryton stent successfully deployed at the intended site? no.What was the final patient outcome? mv - 0% timi 3 flow, sb - 0% timi 3 flow.

• 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: 8787568
• Report Number: 3007210870-2019-00005
• Device Sequence Number: 1668145
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBD24B100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/14/2019
• 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: Life Threatening
• Patient Age: 56 YR
• Patient Weight: 178