MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX Z+; ODE

Model Number	R2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Perforation of Esophagus (2399); Pleural Empyema (4459)
Date of Event	11/15/2023
Type of Reportable Event	Death
Event or Problem Description
A patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted either laparoscopically or robotically, followed by a transoral incisionless fundoplication (tif) procedure).Per the physician, the tif procedure was completed uneventfully and the esophyx device performed as intended.Following both procedures, the patient remained in the hospital and was diagnosed with coronary artery disease, esophageal ischemia, and an esophageal perforation during hospitalization.The patient underwent a ct scan, barium swallow, and an esophagram on unknown dates.An endoscopy was performed on an unknown date to repair the esophageal perforation and to place a stent and chest tube.Per the physician, the patient passed away sometime between (b)(6) 2023 and (b)(6) 2023.
Additional Manufacturer Narrative
The esophyx device was discarded at the medical facility by the hospital staff and is unavailable for return to egs for evaluation.The tif physician stated that the cause of the post procedure event may be due to perforation or fastener erosion.The physician also indicated that the patient's underlying unknown/undiagnosed comorbidities (including coronary artery disease) may have contributed to or caused the patient's outcome.Thus, it is unknown if the tif procedure contributed to and/or caused the patient's outcome.Based on the available information received by egs and the medical opinion of the tif physician, the root cause of the patient's outcome cannot be determined.It cannot be conclusively determined if the hhr procedure, tif procedure, the patient's unknown/undiagnosed comorbidities (including coronary artery disease), or a combination of events, contributed to or caused the adverse event.This event is being filed in an abundance of caution due to this uncertainty.
Additional Manufacturer Narrative
Endogastric solutions reviewed this event/mdr with dr.(b)(6), md, who provided his medical opinion on the associated harm(s) which should be trended for this event/mdr.Per dr.(b)(6) medical opinion, the health effect - clinical code field has been updated to reflect ischemia, esophageal perforation, and empyema as the harms associated with this report.As there is no health effect - clinical code for death, "death" has been selected in section h1 on the 3500a form.
Additional Manufacturer Narrative
A medwatch initial final report is being submitted due to a retrospective review of egs complaints [3005473391] by merit medical's systems inc, [1721504] pms team for any identified complaint discrepancies requiring submissions, corrections and/or additional information per 21 cfr 803.Merit medical, 1600 west merit parkway, south jordan, ut 84095, 801-253-1600.Corrections to egs medwatch report: b.7 - history updated to include transoral incisionless fundoplication (tif), hiatal hernias [hh], gerd, perforation.D6a - implant date added.Updated g code to 788.Replaced d code to include 67.

• Brand Name: ESOPHYX Z+
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th street; suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th st; suite 100; redmond WA 98052
• Manufacturer Contact: darin hammers ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 4253079201
• MDR Report Key: 18553327
• Report Number: 3005473391-2024-00208
• Device Sequence Number: 18041615
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250719(10)403595
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2024

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 Expiration Date: 07/19/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403595
• 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: 12/31/2023
• Supplement Date Received by Manufacturer: Not provided; 08/26/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/29/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2023
• 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
• Patient Sex: Male