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

Catalog Number MAXX-2315/A

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The evaluation is in process.A follow up report will be submitted when the evaluation has been completed.

Event Description

The physician reported that the stent broke during repositioning in the gastro esophageal junction while treating a leak.The physician used a rat tooted forceps to grab the proximal suture to reposition the stent proximally.The suture and part of the stent broke.The physician used a rigid forceps to remove the section.A new stent was used to successfully treat the leak.

Manufacturer Narrative

Device evaluation one device was returned for evaluation.During visual inspection the device was found to be fractured into two pieces and the suture was detached from the stent.The complaint is confirmed.The root cause is unknown.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.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: jerry mcphie ; 1600 west merit parkway; south jordan 84095 ; 8012084491
• MDR Report Key: 4939885
• MDR Text Key: 22944365
• Report Number: 1721504-2015-00122
• 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: Other
• Report Date: 06/25/2015

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: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: MAXX-2315/A
• Device Lot Number: IPX2153U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1