MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDO MAXX ESOPHAGEAL STENT

Catalog Number MAXX-2315/C

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges the stent they were using was placed for an off label indication, an esophageal perforation.Patient was a (b)(6) year old, relatively healthy male, with an otherwise healthy esophagus.The stent was placed at about 28 cm from the incisors and bridges the ge junction.Stent was left in place for 6 weeks.The patient had a lot of reflux post stent placement and also while the stent was in place.Patient also has a history of gerd.The account suggests that it is chronic reflux and possible contracting of the esophagus which caused the stent to fracture while in place.The accounts concern is that the stent began to degrade before removal.You can see the tissue protruding through the stent lining on the endoscopic photos.Once the physician started to remove the stent (rat tooth forceps) it broke apart.Initially at the proximal end.The doctor then used the distal suture to invert the stent.The stent was placed for esophageal perforation.The perforation was completely healed.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: ENDO MAXX 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: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 7261512
• MDR Text Key: 99991844
• Report Number: 3010665433-2018-00010
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

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: Physician
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: MAXX-2315/C
• Device Lot Number: E1168316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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 Age: 59 YR