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

Catalog Number	T5-2525-191-US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tryton device lot number was unavailable.Multiple attempts to locate the lot number were unsuccessful.Patient: unspecified patient injury.Clarification of the 'patient injury' was not available from the site other than the comment, 'the patient was discharged from the hospital after 3 ½ days.He initially had an impel put in and was in icu.' no further details were available.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: artery was reported to have had high tortuosity.The current ifu includes the following contraindication: "target lesion has excessive tortuosity unsuitable for stent delivery and deployment.".
Event or Problem Description
During a percutaneous coronary intervention with a 2.5/2.5 mm x 19 mm tryton coronary stent delivery system at a bifurcation lesion in the circumflex artery and obtuse marginal, as the physician was positioning the tryton stent he realized he had to pull back some.In doing so, he encountered some tortuosity of the artery and during pull back the tryton stent fell off the balloon.The stent fell off in the anatomy and they trapped the tryton with a drug eluting stent against the interior lumen.There was an unspecified patient injury (no further details were available).The patient was discharged from the hospital after 3 1/2 days.He initially had an impel put in and was in icu.Per the clinician's follow up, the patient is non-symptomatic and doing quite well.What was the medina classification? 1,1,1.What was percent stenosis? 60%.What was the degree of calcification? low.What was the degree of tortuosity? high.Was there difficulty reaching the lesion? lesion - none.Was there difficulty crossing the lesion? no.Were multiple dilatations performed during the attempt to place the tryton stent? yes.

• 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: 7278558
• Report Number: 3007210870-2018-00003
• Device Sequence Number: 2249041
• Product Code: MAF
• UDI-Device Identifier: 00894588002125
• UDI-Public: 00894588002125
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: T5-2525-191-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/16/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR