MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ALIMAXX-ES; PROSTHESIS, ESOPHAGEAL

Model Number 00884450030653

Device Problem Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

Account alleges that an esophogeal stent placed for an esophageal fistula was filled with water a leak was found.The implanted stent had a pin hole.The account reports that the stent was replaced.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ALIMAXX-ES
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 10511873
• MDR Text Key: 206293446
• Report Number: 3010665433-2020-00034
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 00884450030653
• UDI-Public: 00884450030653
• Combination Product (y/n): N
• PMA/PMN Number: K080838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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: 00884450030653
• Device Catalogue Number: 80129-203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR