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

Catalog Number MAXX-1910/A

Device Problems Break (1069); Migration or Expulsion of Device (1395); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

The physician reported that two telescoped esophageal stents migrated into the stomach.The physician grasped the proximal suture and attempted to remove both stents through the esophagus.The proximal stent broke within the first three strut rows.The physician grasped the distal suture of the proximal stent, inverted the stent and removed it.The physician noticed that a piece of the stent was missing, went back in with the scope and removed it.No patient harm or injury was reported.

Manufacturer Narrative

Device evaluation.The suspect device was not returned for evaluation.The device history record was reviewed and found no exception documents.The complaint database was reviewed no similar complaint were for this lot number.Merit is unable to determine a root cause without the actual device.

• Brand Name: ENDOMAX ESOPHAGEAL STENT
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• Manufacturer Contact: jerry mcphie ; 1600 west merit pkwy.; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 3886311
• MDR Text Key: 4422310
• Report Number: 1721504-2014-00077
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: MAXX-1910/A
• Device Lot Number: IPX0178U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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