MAUDE Adverse Event Report: INTERSECT ENT PROPEL (MOMETASONE FUROATE IMPLANT 370 UG); DRUG ELUTING SINUS STENT

Model Number 70011

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

Patient Problems Headache (1880); Inflammation (1932); Blurred Vision (2137)

Event Date 08/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a (b)(6) year old male with a history of chronic sinus disease and asthma underwent endoscopic sinus surgery and two propel sinus implants were placed bilaterally in the ethmoid sinuses.The pt was placed on antibiotics for 10 days post operatively.On day one, post-op packing was removed and daily saline sinus irrigations were started.On (b)(6) 2014 (2 weeks post-op) the pt complained of significant headache, decrease in visual acuity, and ocular pain.During the 2 week post-operative visit, the physician observed both peri-orbital and lamina papyracea inflammation; he opted to remove the implants and placed the pt on oral steroids.The pt was referred to an ophthalmologist, who did not observed any ocular pathology or prescribed any additional medications.A ct scan was performed and it was reported on (b)(6) 2014, that the sinuses were clear of any subsequent issues.The pt's eye symptoms had lessened, however he continued to experience headaches.This report is based on info available to the company at the time the report was due for submission and may not reflect all info that may ultimately become available through requests or analysis.

Manufacturer Narrative

Based on a review of internal records, the company was not able to establish a failure to meet specification.However, out of an abundance of caution, the company is submitting the report.

• Brand Name: PROPEL (MOMETASONE FUROATE IMPLANT 370 UG)
• Type of Device: DRUG ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT; menlo park CA
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025 ; 6506412115
• MDR Report Key: 4117509
• MDR Text Key: 19402369
• Report Number: 3010101669-2014-00005
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100044
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2015
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 40520001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Required Intervention
• Patient Age: 51 YR