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

Catalog Number MAXX-2312

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 01/15/2014

Event Type  Injury  

Event Description

The user reported that the device had migrated to the stomach.Prior to device removal the stricture (approximately 3cm above upper esophageal sphincter) was dilated to 15 cm.The device got struck within the stricture and the suture broke during this initial removal attempt.The device was left in place.The patient developed symptoms later and was admitted to the hospital that night.The device was removed by a thoracic surgeon at the hospital.The physician broke the device into pieces while pulling it through a rigid scope.The pt remained in the hospital over night for observation and was released the next day.No harm or injury was reported.

Manufacturer Narrative

Device evaluation: no device is expected to be returned for evaluation.The implant date was not provided and is an estimate.The user did not provide a lot number.A review of the device history record and complaint database for lot specific info could not be completed.A follow up report will be submitted if additional info becomes available.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: paul kennedy ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084301
• MDR Report Key: 3672036
• MDR Text Key: 4339931
• Report Number: 1721504-2014-00020
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MAXX-2312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2014
• 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): Hospitalization; Required Intervention