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 Code	Pulmonary Embolism (1498)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
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).The tif procedure was uneventfully completed, and the patient was discharged.On the next day following the procedures, the patient returned to the hospital complaining of shortness of breath and was admitted.The patient underwent bloodwork and a ct scan on an unknown date and was diagnosed with a pulmonary embolism.Anticoagulant medication was administered.The patient was discharged on an unknown date.
Additional Manufacturer Narrative
The physician is not alleging a product malfunction contributed to or caused the adverse event and the device was not returned to endogastric solutions (egs) for evaluation.The device was discarded at the medical facility by hospital staff and is unavailable for return to egs.Per the physician, the pulmonary embolism possibly occurred due to distant history of pulmonary embolism.Based on the available information received by egs, the cause of the reported pulmonary embolism cannot be conclusively determined.It cannot be conclusively determined if the patients prior history of pulmonary embolism diagnosis, hhr procedure, tif procedure, or a combination of both these contributed to or caused this adverse event.
Additional Manufacturer Narrative
This medwatch supplemental report is being submitted due to a retrospective review of egs complaints [(b)(4)] by merit medical's systems inc, [(b)(4)] pms team for any identified complaint discrepancies requiring corrections/additional information per 21 cfr 803.Merit medical systems inc.(b)(6).Corrections to this medwatch report: d6a - implant date was added updated g3- date received by manufacturer merit medical updated/replaced g code to include: 788 updated/replaced b code to include: 4114 updated/replaced c code to include: 3221 updated/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 ; 6784279065
• MDR Report Key: 19084349
• Report Number: 3005473391-2024-00217
• Device Sequence Number: 15524599
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250626(10)403587
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/24/2024

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: 06/26/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403587
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 148 KG