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

Catalog Number	T5-3035-151-US
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device implanted - not returned to manufacturer.
Event or Problem Description
(b)(6) yo male presenting to the rex ed with anterior stemi.Patient given asa and a loading dose of p2y12 inhibitor and heparin and brought emergently to the cath lab.En route or on arrival to the cath lab, the patient became electrically unstable with multiple bouts of vt-vf requiring multiple shocks (~ 10) and amio load after which stabilized.Baseline angio demonstrated 3 vd including a proximal lad (ira) long tubular and long tubular lesion in moderate size d2 (1.1.1).After consultation with cardiac surgery, it was decided to proceed with a pci-strategy.Via a 6 fr (via a femoral approach) both lad and diag wired.Diag was pre-dilated with 2.5 balloon.Initial attempt to deliver tryton side branch stent was unsuccessful.Tryton was removed, after which additional dilation was performed.Tryton was reintroduced.Additional attempt to track tryton across the d2 lesion was unsuccessful.Tryton was then removed.When tracking a dilation balloon across the diag origin, difficulty was encountered.Examination of the tryton stent delivery balloon revealed absence of the stent.Evaluation of the fluoro image identified the tryton stent in the lad.Initial attempts to track a dilation balloon through tryton into diag were successful.A wire was then introduced through the tryton and into the distal lad over which a dilation balloon was successfully tracked and inflated.A workhorse des was then introduced but was unable to track to into the tryton.Subsequent attempts to track stents or balloons into lad were unsuccessful.Patient then taken to or for emergent cabg.Follow-up on post op day 4, the patient is doing well, extubated and ambulating and doing well.

• 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: 6731556
• Report Number: 3007210870-2017-00005
• Device Sequence Number: 724957
• Product Code: MAF
• UDI-Device Identifier: 00894588002187
• UDI-Public: 00894588002187
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/23/2017

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: T5-3035-151-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• 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: AMIODARONE; ASA; HEPARIN; P2Y12 INHIBITOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR