MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. STENT.ESOPHAGEAL MAXX; PROSTHESIS, ESOPHAGEAL

Catalog Number	MAXX-2310
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that the customer was dx with malignancy at the ge junction, and a competitor's esophageal stent was placed at another hospital.On wednesday, (b)(6) 2023, an egd was performed where the competitor's stent was identified to have migrated into the stomach.The distal esophagus was strictured down, where they could not pass a pediatric egd stomach to retrieve the stent.The decision was made to use an esophageal stent to open the stricture and have a follow-up egd to retrieve the competitor's stent.The physician placed an esophageal stent and then decided to telescope another stent overlapping 3 cms.They brought patient back on friday (b)(6) to perform egd to pull the competitors' stent into the esophageal stent and then remove all remaining stents.When removing the most proximal stent all 3 stents were still connected and moving together.The proximal end broke off in the patient.The physician tried using a dual channel scope and remove using two graspers but was unable to.The decision was then made to admit patient and bring in ent surgeon to assist.On sunday (b)(6), the ent surgeon performed a suspension laryngoscopy and was able to remove the esophageal stent.The stents came out together, and then the physician went down and removed the competitor's stent.No injury to report.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint could not be confirmed, and the root cause is attributed to use error as the ifu was not followed.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: STENT.ESOPHAGEAL MAXX
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 17965414
• Report Number: 1721504-2023-00075
• Device Sequence Number: 6790755
• Product Code: ESW
• UDI-Device Identifier: 00884450442371
• UDI-Public: 00884450442371
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/02/2023

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-2310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Other; Hospitalization
• Patient Sex: Unknown