MAUDE Adverse Event Report: Merit Medical Systems Inc. EndoMAXX Stent; PROSTHESIS, ESOPHAGEAL

Catalog Number	MAXX-1910
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: EndoMAXX Stent
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): Merit Medical Systems Inc.; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): Merit Medical Systems, Inc.; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50778692
• Report Number: 3010665433-2026-00018
• Device Sequence Number: 21503523
• Product Code: ESW
• UDI-Device Identifier: 00884450610732
• UDI-Public: 00884450610732
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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
• Device Catalogue Number: MAXX-1910
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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