MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO.HERO®.SUPERHERO..; VASCULAR GRAFT PROSTHESIS

Catalog Number	SUPERHERO
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 established.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
Customer alleged that during a previous case, approximately one month after insertion, the arterial component of a merit superhero graft became loose from the adaptor and the venous outflow component position changed.The device cannot be returned, as this was an emergency case.The doctors disposed of it after it was exchanged.The patient remained stable, but emergency treatment was required.

• Brand Name: HERO.HERO®.SUPERHERO..
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut 84095 ; IR 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
• MDR Report Key: 24498524
• Report Number: 1721504-2026-00886
• Device Sequence Number: 9960653
• Product Code: DSY
• UDI-Device Identifier: 00884450564325
• UDI-Public: 00884450564325
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SUPERHERO
• Device Lot Number: H2941836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/03/2026
• 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: Other
• Patient Sex: Unknown