MAUDE Adverse Event Report: MERIT MEDICAL PEARLAND ENDOMAXX ESOPHAGEAL STENT; ESOPHAGEAL STENT,

Catalog Number MAXX-2312/C

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

Patient Problem Abrasion (1689)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a follow-up appointment, the physician noted that the stent had migrated into the patient's stomach.This was verified via flexible scope images.The stent was placed on (b)(6) 2017 for malignant esophageal cancer.No difficulties were noted during stent placement.The patient had been undergoing radiation treatment post-stent placement.The physician tried to remove the stent with a pair of "rat tooth" forceps but was unsuccessful.A snare was then used to successfully remove the stent from the patient.During retrieval, some minor abrasions and esophageal bleeding was noted.No serious injury to report.A new stent will be placed in the near future.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint of migration could not be confirmed, however, the returned device was found to be torn.The root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT,
• Manufacturer (Section D): MERIT MEDICAL PEARLAND; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL PEARLAND; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 92154
• MDR Report Key: 7365553
• MDR Text Key: 103674504
• Report Number: 3010665433-2018-00016
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K116111
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: MAXX-2312/C
• Device Lot Number: E885684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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