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 an esophageal stent rubbed against the cardia of the stomach causing a lesion.The stent was placed across the gej and left in place for two months.The stent was removed and no additional stents were required.The patient was sent home and has since expired.The cause of death and date of death was not available.

• 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: 5286900
• MDR Text Key: 33209353
• Report Number: 1721504-2015-00224
• 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: Physician
• 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
• Is the Reporter a Health Professional?: Yes
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention