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

Model Number 70011

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fungal Infection (2419); Surgical procedure, additional (2564)

Event Date 06/06/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 a (b)(6) pt underwent endoscopic sinus surgery with ethmoidectomy and a propel sinus implant was placed in the right ethmoid sinus.The pt was placed on an antibiotic regimen and daily neilmed sinus rinse irrigations starting day one after his procedure.On (b)(6) 2014 the physician noted a superficial fungal infection in the right ethmoid sinus during follow up.The pt complained of sever pain during debridement in the operating room under anesthesia and removed the implant.The pt was discharged with antibiotics and anti-fungal therapy.On (b)(6) 2014 physician reported the fungal infection had fully resolved and there was no sign of chronic infection, and the sinus was healing as expected.

Manufacturer Narrative

Based on the company's complaint investigation, the device met its specs.

• Brand Name: PROPEL (MOMETASONE FUROTE 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: 3987593
• MDR Text Key: 15908363
• Report Number: 3010101669-2014-00003
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): N
• 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: 07/25/2014

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: 03/25/2015
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 40325001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 39 YR