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

Catalog Number MAXX-2315/C

Device Problem Hole In Material (1293)

Patient Problem Impaired Healing (2378)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user reported that a stent was placed to treat an esophageal perforation, but was removed at a follow up examination due to minimal progress.After the stent was removed, a hole was noticed and speculated to be the cause of the perforation not healing.A new stent was placed to continue the process.

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 ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL 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: 5575237
• MDR Text Key: 42608096
• Report Number: 3010665433-2016-00028
• 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: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: MAXX-2315/C
• Device Lot Number: E911541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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