MAUDE Adverse Event Report: Merit Medical Systems Inc. HeRO.HeRO®; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number	HEROGRAFT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	06/30/2026
Type of Reportable Event	Death
Event or Problem Description
The subject in a merit hero graft clinicial trial was admitted on (b)(6)2026 for acute on chronic hypoxic respiratory failure.On (b)(6)2026, a code was called for agonal breathing and profound bradycardia that became pulseless electrical activity (pea) arrest.Cardiopulmonary resuscitation (cpr) was initiated on the patient resulting in intubation and transfer to the intensive care unit (icu).Subject continued to experience profound bradycardia and pea arrest despite several rounds of iv medications/fluids and the use of a lucas device.Subject coded multiple times for over a period of 5 hours.All efforts were eventually deemed futile and stopped.The patient expired.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the product history and complaint database could not be performed since the lot number was not provided.

• Brand Name: HeRO.HeRO®
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50052736
• Report Number: 1721504-2026-00183
• Device Sequence Number: 13127131
• Product Code: DSY
• UDI-Device Identifier: 00884450563922
• UDI-Public: 00884450563922
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K213845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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
• Device Catalogue Number: HEROGRAFT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown