MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SEROSAFUSE IMPLANTABLE FASTENER KIT; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Catalog Number	R2275
Medical Device Problem Codes	Mechanical Problem (1384); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Weight Changes (2607); Stenosis of the esophagus (4487); Swelling/ Edema (4577)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return 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.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that a patient returned with a stricture approximately 30 days post-ctif procedure.The primary ctif procedure occurred on (b)(6) 2024.The patient returned to the hospital (b)(6) 2024 and was experiencing dysphagia, vomiting, and nausea at the time.An x-ray demonstrated some mild narrowing of the ge junction.An egd was performed on (b)(6) 2024 and demonstrated severe stenosis 4cm in length.The physician states that he was unable to pass a scope into the patient's stomach during the egd procedure until after a 15mm balloon dilation attempt.The patient has been dilated with bougie 3 times since the original ctif procedure.The physician identified several long tif fasteners extruding out into the esophageal junction just above the egj.The protruding fasteners were likely the cause of the esophageal stricture identified within this patient.The physician used endoscopic scissors to cut 4 fasteners that were protruding into the lumen of the esophagus and stated that it looked like the esophagus had relaxed up a bit.The physician injected botox.Plans to insert peg tube in 2 weeks for nutrition if all interventions fail.The physician states that all interventions were necessary to prevent impairment.The esophyx device used during the tif procedure operated as intended with no malfunctions to report.

• Brand Name: SEROSAFUSE IMPLANTABLE FASTENER KIT
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC; 1600 merit parkway; south jordan UT 84084
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84084 ; 8012531600
• MDR Report Key: 20309767
• Report Number: 1721504-2024-00070
• Device Sequence Number: 18359360
• Product Code: ODE
• UDI-Device Identifier: 00810275014011
• UDI-Public: 810275014011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: 172811
• 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): 09/06/2024

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: R2275
• 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: 09/06/2024
• Initial Report FDA Received Date: 09/26/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 57 KG