MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT; DRUG ELUTING SINUS STENT

Model Number 70011

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Discomfort (2330)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

The surgeon reported the implant was correctly positioned (aligned to the anterior edge of the middle turbinate).There was no repositioning/adjustment of the implants after placement.The implant was well opposed to sinus mucosa.The following is being provided as this device is a combination product: name: propel, dose, frequency & route used: (1) 370 ug implant, diagnosis for use: sinus surgery.Combination product -yes.Age, weight, lot number are unknown.

Event Description

The patient underwent endoscopic sinus surgery (ess) and concomitant septoplasty with septal splints to treat chronic sinusitis with nasal polyps.Sinus implants were placed bilaterally in the ethmoid sinuses without incident.Septal splints (trimmed) were placed anterior to the middle turbinate after placement of the sinus implants.It is unknown whether the septal splints contacted the sinus implants.Within 12 hours of surgery, the patient felt "discomfort" in the back of his throat and went to the er.Upon examination by the ent physician on call, it was reported that the implant from the right side had migrated to the back of the patient's throat.The left side implant remained in place.The er physician removed the implant through the patient's oral cavity.The patient was seen by the surgeon one week post-op and reported to have experienced no harm from the migration and subsequent removal of the implant.The surgeon indicated that it is plausible that the septal splints could have potentially caused the dislodgement of the sinus implant.The patient is reportedly doing fine.

• Brand Name: PROPEL SINUS IMPLANT
• Type of Device: DRUG ELUTING SINUS STENT
• Manufacturer (Section D): INTERSECT ENT; menlo park CA
• Manufacturer (Section G): INTERSECT ENT; 1555 adams dr; menlo park CA 94025
• Manufacturer Contact: amy wolbeck ; 1555 adams dr; menlo park, CA 94025 ; 6506412115
• MDR Report Key: 5649020
• MDR Text Key: 45005525
• Report Number: 3010101669-2016-00004
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2016

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: Physician
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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