MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC ENDOMAXX ESOPHOGEAL STENT

Catalog Number MAXX-2315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The investigation is in progress and a follow up will be submitted upon completion.Since the lot number was not provided, a review of the device history record and complaint database could not be performed.

Event Description

During a scheduled removal, the stent appeared to be fractured with cover degradation and in-growth.Stent was grasped with rat tooth forceps by the removal suture.Physician reported removal was somewhat complicated as they were stuck at the oropharynx.Patient began to de-sat.As anesthesia was preparing to emergently intubate, the physician was able to grasp the suture again and remove the stent.Further evaluation revealed some usual trauma to the esophagus and what the physician referred to as possible "micro perforations.".

Manufacturer Narrative

The returned device was determined to be a different part number than the customer reported.The complaint stating a torn cover and broken struts on the distal end was confirmed.It is unknown if this damage occurred while the stent was in the patient or during removal.

• Brand Name: ENDOMAXX ESOPHOGEAL STENT
• Type of Device: ESOPHOGEAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5540140
• MDR Text Key: 41614201
• Report Number: 3010665433-2016-00021
• Device Sequence Number: 1
• Product Code: ESW
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MAXX-2315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening