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

Model Number 70011

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/02/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a male pt had functional endoscopic sinus surgery (fess) and was treated with propel sinus stents bilaterally in the ethmoid sinuses.The physician performed an anterior ethmoidectomy, used balloon therapy in the maxillary and frontal sinuses and had uncapped the bulla.The physician used evicel fibrin sealant for hemostasis.On (b)(6) 2014, 4 days post surgery, the implant migrated from the left sinus to the throat.The physician initially reported that the pt was choking and that the airway was obstructed, and later clarified that the pt described feeling something in his throat, felt a chocking sensation and coughed up the implant.It was confirmed the pt did not receive assistance from a third party at the time of the event.The pt brought the implant to the physician the following day and it was discarded.There were no issues reported with right implant.The pt was reported to have to subsequent tissues post event and no additional medical intervention was required.

Manufacturer Narrative

Based on the company's complaint investigation, the device met its specifications.In an abundance of caution, intersect ent is reporting this event is a malfunction based on the info it received the remote possibility of serious injury should a similar event occur.

• Brand Name: PROPEL (MOMETOSONE 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: 3979430
• MDR Text Key: 4884198
• Report Number: 3010101669-2014-00002
• 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: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2014
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 31018001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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