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

Model Number	R2007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Optical Obstruction (3002)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The alleged 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 resulted in no non conformances which could cause or contribute to the reported issue.Should the device be at a later date, the investigation will be reopened.
Event or Problem Description
A patient underwent a hiatal hernia repair (hhr) procedure followed by a transoral incisionless fundoplication (tif) procedure.At least one bougie was used prior to the insertion of the esophyx device to dilate the esophagus.During the tif procedure, per the physician, there was difficulty disengaging the helix from tissue at one placement site.Once the helix was disengaged from the tissue at the placement site, some tissue was noted remaining in the helix coil and a bleed, not requiring transfusion was noted at the helix placement site.The physician attempted to continue the procedure and noted difficulty engaging the helix at other placement sites with the noted tissue remaining in the coil.Additionally, the physician noted impacts to visibility due to the bleed and decided to remove the esophyx device.The physician inserted an endoscope and injected epinephrine at the bleeding site.Additionally, seven hemostatic clips were placed near the bleeding site, however the noted bleeding continued.Pura-stat was applied to the distal esophagus at the z-line and a covered esophageal stent was placed in the distal esophagus.Per the physician, there may have been muscularis tissue which was removed and remained in the helical coil of the esophyx device.Per the physician, no perforation was seen, and the covered stent was placed as a precaution.The patient reportedly remained stable throughout the procedure with no change in vital signs.The physician is reportedly planning to bring the patient back at a later date to finish the tif procedure.
Additional Manufacturer Narrative
This medwatch supplemental report is being submitted for more robust device coding and use of annex a as requested by the fda.Merit medical systems inc.(b)(6).Corrections/additions and or edits to this medwatch report: updated a codes to include 1250,1384, 1670 and 3002.

• 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: shala famil ; 18109 ne 76th st; suite 100; redmond 98052 ; 4087055521
• MDR Report Key: 20042259
• Report Number: 3005473391-2024-00231
• Device Sequence Number: 8117314
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)251010(10)403651
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/22/2024

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: 10/10/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403651
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2023
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG