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

Catalog Number MAXX-2310/C

Device Problems Break (1069); Fracture (1260); Structural Problem (2506); Material Integrity Problem (2978)

Patient Problems Dysphasia (2195); Hernia (2240)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that the stent had roughly been in place for 10 months.The physician was going to remove and replace the existing stent.During an esophagogastroduodenoscopy [egd] a very tight stricture was observed in the mid to lower esophagus however, the stent was not visible.A fluoro image was taken and the stent could be seen distal to the stricture.The stent had migrated and was resting partially in the distal esophagus.Multiple deformities were noted within the existing stent.It was clear that some fractures and tissue ingrowth had occurred.The physician was concerned that the stent would break during the removal attempt, so an additional stent was successfully placed under fluoroscopic guidance.During placement it was noted that there was a significant curve within the patient's esophagus and the stent had an angled appearance.The patient is scheduled to have the stents removed in one week.

Manufacturer Narrative

One device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause is attributed to patient physiology and preexisting conditions.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: ENDOMAXX EVT 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 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 7290868
• MDR Text Key: 100919325
• Report Number: 3010665433-2018-00012
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MAXX-2310/C
• Device Lot Number: E1020051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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