MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS MULTI-SINUS DILATION TOOL; SINUS BALLOON DIALATION SYSTEM

Model Number MSB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 07/02/2014

Event Type  Death  

Event Description

A (b)(6) pt underwent an uneventful, successful bilateral maxillary balloon dilation procedure on (b)(6) 2014.Post-procedure,the patient reported having a headache.The headache worsened and the pt was taken to the er.A ct was taken and showed a massive intracranial bleed reported to be unrelated to device or procedure.Entellus medical was notified on (b)(6) 2014 of the incident and notified on (b)(6) 2014 of the pt's death.Cause of death was due to intracranial bleed and assessed to be unrelated to device or procedure.

Manufacturer Narrative

Both the ent and hospital physicians stated that the event was not related to the device or procedure.In additional, the treating hospital physician stated that the pt would have had the event regardless of whether or not the procedure was performed.There is no indication that suggests the device or procedure caused or contributed to the reported event.Therefore, this mdr is being filed for notification purposes only.

• Brand Name: XPRESS MULTI-SINUS DILATION TOOL
• Type of Device: SINUS BALLOON DIALATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; plymouth MN 55447
• Manufacturer Contact: karen peterson ; 3600 holly lane north; suite 40; plymouth, MN 55447 ; 7634637066
• MDR Report Key: 3995004
• MDR Text Key: 4819417
• Report Number: 3006345872-2014-00003
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB
• Device Catalogue Number: LPLF-106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Death
• Patient Age: 70 YR