MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT

Model Number 70011

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Fungal Infection (2419)

Event Date 12/01/2013

Event Type  Injury  

Event Description

A (b)(6) year old male with chronic lymphocytic leukemia developed an invasive right side fungal sinusitis approximately 2 weeks after endoscopic sinus surgery including bilateral placement of propel implants.Endoscopic examination at week 1 was unremarkable and sinuses appeared to be healing normally.Patient subsequently developed right-sided sinus and ocular pain and was treated by primary care physician with antibiotics and oral steroids within 2 weeks of surgery.Patient's symptoms persisted.Subsequent weekly endoscopic exams indicated recurrent edema throughout the right sinus anatomy.The implants were removed at 2 weeks; macroscopically there was no sign of fungal colonization.Given persistence of orbital pain, patient was taken back to the operation room for a debridement at week 3.Tissue specimens taken from the ethmoid sinus and lamina papyracea tested positive for invasive fungus.Condition has been treated with dual iv antifungal therapy and additional sinus debridements.As the patient was immunocompromised and had received oral steroids and iv antibiotics during post-op week, the exact root cause of the fungal sinusitis is unknown.

• 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: 3631871
• MDR Text Key: 17391773
• Report Number: 3010101669-2014-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2014
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 30815001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR