MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDOMAXX®; PROSTHESIS, ESOPHAGEAL

Catalog Number	MAXX-2315/E
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Stenosis of the esophagus (4487)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a patient came in for a check up due to narrowing esophagus two years post esophogeal stent placement.A revision of the stent was scheduled.Upon removing the implanted stent, it was found that it had ruptured allowing granulation tissue to grow within.Due to the patient's history of esophogeal cancer, a new esophogeal stent is required.Additional information states that treatment was not able to be completed successfully and that foreign body was introduced into the patient and that a retrieval basket was used to remove it.
Additional Manufacturer Narrative
The suspect device was returned for evaluation the stent frame was broken towards one of the ends.The pieces of the nitinol metal frame that broke had residual granulation tissue growth around the area.No other observations could be made.The most probable root cause is environment related to the patient condition.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.Non-conformances of this nature are monitored by the engineering, quality and management team members.

• Brand Name: ENDOMAXX®
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• 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: 22566363
• Report Number: 1721504-2025-00176
• Device Sequence Number: 13098407
• Product Code: ESW
• UDI-Device Identifier: 00884450610855
• UDI-Public: 00884450610855
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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-2315/E
• Device Lot Number: E2322828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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