MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC ESOPHYX Z+; ENDOSCOPIC SUTURE/PLICATION SYSTEM

Catalog Number	R2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Chest Pain (1776); Perforation of Esophagus (2399)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned for engineering 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.
Event or Problem Description
The account alleges the physicians successfully performed a concomitant hiatal hernia repair with endoscopic fundoplication (ctif) on (b)(6) 2024 without complications.No medical device malfunction noted.Approximately 13 days later, the patient returned to medical center reporting chest pain.A ct scan in the emergency department revealed a suspected abscess, likely caused by a leak at the gastroesophageal junction.The physician successfully drained the abscess.Mesh had been placed during the initial procedure, which may have been a contributing factor.The patient was admitted and was discharged on (b)(6) 2024 in stable condition.

• Brand Name: ESOPHYX Z+
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM
• 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: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 20258277
• Report Number: 1721504-2024-00066
• Device Sequence Number: 20704173
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIATAL HERNAI REPAIR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown