MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING ENDOMAXX®.STENT; PROSTHESIS, ESOPHAGEAL

Catalog Number	MAXX-1910/D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The physician alleges that post esophageal stent deployment; a patient had expired.The physician states that the esophageal stent was successfully deployed to seal a 4cm long benign refractory stricture at 28 cm from the incisors.After multiple dilatations the esophageal stent was sutured in place using an endoscopic stitching device.The stent was in place for 6 weeks without complications when the patient presented with food and pill impaction.The impaction was removed, and stent was left in place.Seven to eight weeks later the patient presented with hypertension and hematemesis.The physician states that within six hours of arriving at the hospital the patient expired.
Additional Manufacturer Narrative
The suspect medical device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned, the investigation will be reopened.

• Brand Name: ENDOMAXX®.STENT
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 15510160
• Report Number: 3010665433-2022-00096
• Device Sequence Number: 12057510
• Product Code: ESW
• UDI-Device Identifier: 00884450442234
• UDI-Public: 884450442234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/08/2022

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: MAXX-1910/D
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APPOLO - OVERSTITCH ENDOSCOPIC SUTURING.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown