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 Code	Foreign Body In Patient (2687)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference medwatch report mw5087479.Production records and trend analysis were reviewed with no device problem found.Because device has not been returned, a definitive conclusion by tryton could not be reached.Medium calcification reported."vessels that have moderate to severe calcification" are contraindicated in the ifu.
Event or Problem Description
The tryton stent came off the balloon in the patient.No attempt to retrieve it [the stent].He [doctor] crushed it against the wall of the lad.The patient was not injured.What was the target lesion (mv and sb)? lad/dia.What was percent mv and sb stenosis? 90%.What was the degree of calcification (none/low/medium/high)? medium.What was the degree of tortuosity (none/low/medium/high)? medium.What guide catheter (size and type) was used? xb 3.5.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? yes, [they] could not cross with tryton.Was there difficulty crossing the lesion? yes, [they] could not cross the lesion with tryton.Were multiple dilatations performed during the attempt to place the tryton stent? twice.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? yes once.Describe how and when in the procedure that the tryton stent became dislodged.Include details if attempts were made to withdraw the device into the guide catheter.When it did not cross, removed the device and realized that [the stent] came off the [balloon].Describe any attempts to retrieve the dislodged tryton stent.None.If multiple tryton devices were used during the procedure, include device sizes used (ex.2.5/3.5, 2.5/3.0, etc.).Only 1 was used.
Additional Manufacturer Narrative
H6 - methods: delivery system, but not stent, returned for evaluation.H6 - results: no device problem found for delivery system that was returned and evaluated.No findings available for stent since it was not returned.

• 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: 8796723
• Report Number: 3007210870-2019-00006
• Device Sequence Number: 1978127
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBK21B1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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