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

Model Number 00884450147627

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, ut ; 2084662
• MDR Report Key: 10456610
• MDR Text Key: 204523231
• Report Number: 3010665433-2020-00032
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00884450147627
• UDI-Public: 00884450147627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention