MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT

Model Number 70011

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

Patient Problem Intraocular Pressure Increased (1937)

Event Date 12/01/2014

Event Type  Injury  

Event Description

A patient underwent endoscopic sinus surgery in which drug eluting sinus implants were placed post-operatively bilaterally.The pt received an iv dose of decadron (8-10 mg) intra-operatively.No topical steroids were prescribed to the pt post-operatively.Between the surgery and the 1 week post-op appointment the pt had scheduled a routine visit to ophthalmologist.The pt was exhibiting no symptoms at the time of the visit, however, was informed by the ophthalmologist of increased intra-ocular pressure (iop).The ophthalmologist prescribed eye drops (type unk).At the 1 week post-op visit with the surgeon the stents were removed.The physician did not have info regarding the iop levels prior to the surgery nor the level seen by the ophthalmologist.Additionally, the physician reported there were no complications or pre-existing condition prior to the surgery, which could contribute to the increased iop.The reporting physician believed that the pt's iop had returned to normal levels.Based on the info available, it is unk if the device contributed to the pts reported effect.However, out of an abundance of caution, the company is submitting this report.Refer to mdr 3010101669-2015-00001 for the report on the first implant.

• Brand Name: PROPEL SINUS IMPLANT
• Manufacturer (Section D): INTERSECT ENT; menlo park CA
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025 ; 6506412115
• MDR Report Key: 4478418
• MDR Text Key: 5565205
• Report Number: 3010101669-2015-00002
• 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: 12/31/2014

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: 03/17/2016
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 40917003
• Other Device ID Number: M92770011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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): Other
• Patient Age: 20 YR