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

Model Number	00884450147627
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the stent was initially placed (b)(6) 2019.Patient did not attend any follow ups after placement due to alleged incarceration.Patient was seen in (b)(6) 2020 for possible stent removal as the stent had migrated to the stomach.There is no knowledge of when the stent migrated.Dr.Goodman went into retrieve the stent pulling the proximal loop and it had broken off as he was pulling it through the les.The physician stated that he was able to take out about an inch of the stent.At this point the msl was conferenced in to assist.The remainder of the stent had to be piece-mealed through an over-tube until he was finally able to grab the distal loop suture and pull out the rest of the stent into the over-tube.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: ENDOMAXX ESOPHOGEAL STENT
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10456610
• Report Number: 3010665433-2020-00032
• Device Sequence Number: 3569282
• Product Code: ESW
• UDI-Device Identifier: 00884450147627
• UDI-Public: 00884450147627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 00884450147627
• Device Catalogue Number: MAXX-2310/C
• Device Lot Number: E1604551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention