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	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was later clarified that the stent initially dislodged in the left main and, upon effort to retrieve the stent, the stent became lodged in the profunda femoris artery where it was left.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.) conclusion: high degree of tortuosity and medium degree of calcification reported.The current ifu includes the following contraindications: "target lesion has excessive tortuosity unsuitable for stent delivery and deployment." and "vessels that have moderate to severe calcification.".
Event or Problem Description
Tryton stent came off balloon prior to deployment inside the patient.Tryton was able to be retrieved from the left main coronary artery but it does remain in the patient's profunda femoris artery.The doctor used another tryton (2.5 x 3.0) on this same patient and had no issues with excellent end result.The doctor stated that the patient is doing fine.What was the target lesion? lad/diag.What was percent stenosis? 90.Was the device used for a chronic total occlusion (total occlusion > 3 months)? no.What was the degree of calcification (none/low/medium/high)? medium.What was the degree of tortuosity (none/low/medium/high)? high.What guide catheter (size and type) was used? 7fr.Did the device prep normally (i.E.Maintain negative pressure)? scrub aspirated prior to crossing lesion.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.Was there difficulty crossing the lesion? yes.Were multiple dilatations performed during the attempt to place the tryton stent? yes.Was the tryton stent removed between dilatations? if so, how many times was it removed and was it checked visually for distortion/damage? two times.Describe any attempts to retrieve the dislodged tryton stent: a snare was used then a balloon and guide approach.

• 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: 7430318
• Report Number: 3007210870-2018-00006
• Device Sequence Number: 1950344
• Product Code: MAF
• UDI-Device Identifier: 00894588002132
• UDI-Public: 00894588002132
• Combination Product (Y/N): N
• PMA/510(K) Number: P150039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: Physician
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: T5-2530-191-US
• Device Lot Number: UBC01B1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/13/2018
• 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: Required Intervention
• Patient Age: 70 YR