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

Catalog Number MAXX-2315

Device Problem Device Issue (2379)

Patient Problem Fistula (1862)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation 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.Since the lot number was not provided, the device history record and complaint database could not be reviewed.

Event Description

The user reported that the stent eroded through the esophagus resulting in a te fistula at the proximal flare of the stent.The original stent was placed on (b)(6) 2015 to treat post esophageal leak from procedural complications.That stent was removed (b)(6) 2015.A te fistula was observed with a small area of necrosis.The patient received a new stent to treat the te fistula.No further harm or injury to the patient was reported.

• Brand Name: ENDOMAXX ESOPHAGEAL STNET
• Type of Device: ESOPHAGEAL STNET
• 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: 5285823
• MDR Text Key: 33167589
• Report Number: 1721504-2015-00225
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MAXX-2315
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention