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

Catalog Number MAXX-2312/C

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

No device is expected to be returned for evaluation.A review of the device history record and complaint database is in progress.A follow up will be submitted upon completion.

Event Description

It was reported that a patient vomited up an esophageal stent three days after it had been placed.The stent was originally placed for an esophageal perforation.The physician reported that the perforation healed during the time the stent was in place and the patient is now doing fine.

Manufacturer Narrative

No device is expected to be returned for investigation.The device history record was reviewed and no exception documents were found.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.

• Brand Name: ENDOMAXX ESOPHOGEAL STENT
• Type of Device: ESOPHOGEAL 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: jerry mcphie ; 1600 west merit parkway; south jordan, UT 84095 ; 8012084491
• MDR Report Key: 5540380
• MDR Text Key: 41613406
• Report Number: 3010665433-2016-00022
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: MAXX-2312/C
• Device Lot Number: E885682
• Was Device Available for Evaluation?: No
• 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
• Date Device Manufactured: 12/10/2015
• 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