MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ALIMAXX ESOPHAGEAL STENT

Catalog Number 80129-205/C

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a stent removal procedure, the physician noted stent ingrowth within the body of the esophageal stent.The stent was successfully removed without consequence to the patient.The stent was originally placed (b)(6) 2018 for a esophagogastric leak.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint is confirmed.The root cause is attributed to patient anatomy.A review of the device history record and complaint database could not be performed since the lot number was not provided.

• Brand Name: ALIMAXX ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8080725
• MDR Text Key: 127451052
• Report Number: 3010665433-2018-00063
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

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: No Information
• Device Catalogue Number: 80129-205/C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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