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

Model Number	R2007
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	04/18/2024
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.Prior to insertion of the esophyx device, the helical retractor was reportedly properly stowed and locked.At an unknown time during device insertion, the helical retractor moved from the stowed position and caused a superficial mucosal tear.The device was uneventfully removed and the procedure was subsequently aborted.The patient was diagnosed with a mucosal tear.The physician placed clips to treat the reported mucosal tear.An esophagram was planned to be performed on (b)(6) 2024.
Additional Manufacturer Narrative
Per the physician, the cause of the reported mucosal tear is due to the helical retractor moving from the proper stowed position during device introduction.Endogastric solutions (egs) has requested the device for evaluation; however, the device is being held at the hospital and is currently unavailable for return to egs.Additionally, the dhr was reviewed, and the dhr was found to be in compliance and no related manufacturing nonconformities were identified.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 mucosal, and perforation 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 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: b2 - added life threatening 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 updated/replaced a code to include: 2907.

• 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: 19347059
• Report Number: 3005473391-2024-00218
• Device Sequence Number: 19484927
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)251023(10)403662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• 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,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: 10/23/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403662
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 76 KG