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

Catalog Number MAXX-2312

Device Problem Device Issue (2379)

Patient Problem Death (1802)

Event Date 11/12/2015

Event Type  Death  

Manufacturer Narrative

Device evaluation: the device is not expected to return 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 a stent caused a perforation to the esophagus of a patient.A merit stent was placed to treat a stricture after the migration of a competitor's stent.The patient returned to the hospital presenting with pain and fever.A perforation was found after the stent was removed.No additional treatment was provided and the patient was discharged to hospice and later expired.The cause of death and date of death were not provided.

• 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: 5285830
• MDR Text Key: 33167872
• Report Number: 1721504-2015-00228
• 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
• Type of Report: Initial
• Report Date: 11/12/2015

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-2312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: WALLFLEX STENT
• Patient Outcome(s): Death; Required Intervention