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

Model Number 00884450030646

Device Problems Defective Component (2292); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2023

Event Type  malfunction  

Event Description

Covered stent was introduced to the point of esophageal malignancy but was defective, did not deploy.

• Brand Name: ALIMAXX-ED
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17070271
• MDR Text Key: 316585326
• Report Number: 17070271
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2023,05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450030646
• Device Catalogue Number: 80129-202/C
• Device Lot Number: MR2258732
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White