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

Catalog Number MAXX-2310/B

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Adhesion(s) (1695)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

No device is expected to be returned for investigation.The complaint database was reviewed and no similar complaints for this lot number were found.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.

Event Description

Physician placed the stent into a patient with a roux y gastric bypass stricture.Patient came in complaining of pain before scheduled removal date.During removal the physician found that the stent had migrated into the duodenum and had become embedded into the duodenal wall.The physician then performed a resection to the area where the stent was embedded and removed it successfully.

• Brand Name: ENDOMAXX® ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL 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: 5354562
• MDR Text Key: 35464949
• Report Number: 1721504-2016-00001
• 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
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: MAXX-2310/B
• Device Lot Number: IPX2383U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2015
• 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