MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HERO®; SYNTHETIC VASCULAR GRAFT, NON-MEDICATED

Catalog Number	HEROGRAFT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
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 device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
On april 1, 2026, information was received regarding a subject participating in a clinical trial.The subject experienced thrombosis of the hero graft requiring medical intervention, including thrombectomy and angioplasty, to restore patency.This event represents a recurrent thrombosis in the same subject, necessitating repeat intervention.The patient outcome following intervention was not further specified.

• Brand Name: HERO®
• Common Device Name: SYNTHETIC VASCULAR GRAFT, NON-MEDICATED
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25048022
• Report Number: 1721504-2026-00019
• Device Sequence Number: 9921382
• Product Code: DSY
• UDI-Device Identifier: 00884450563922
• UDI-Public: 00884450563922
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/30/2026
• 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: Required Intervention
• Patient Sex: Unknown