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

Model Number 60011

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

Patient Problem Perforation (2001)

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

The propel mini sinus implant is intended for use in patients 18 years of age or greater following ethmoid sinus surgery to maintain patency, thereby reducing the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.The propel mini sinus implant separates mucosal tissues, provides stabilization of the middle turbinate, prevents obstruction by adhesions, and reduces edema.During the investigation, the physician's opinion was that because the patient did not have middle turbinates due to prior surgeries, this resulted in the implants sitting against the septum leading to septal perforation due to pressure necrosis through mucosa and cartilage.The radial force exerted by the implant is orders of magnitude smaller than the force required to produce fractures in the nasal septum (lee m, et.Al.Ohns (2010) 143, 784-788).The radial force decreases over time and there are no sharp edges to be pushed into/through the septum.Additionally, based on the company's evaluation and consistent with the reported information from the physician, there does not appear to be any device malfunction.Thus, it is highly unlikely that the implants caused or contributed to the septal perforation in this case.Given this patient's history of chronic sinusitis with persisting nasal polyposis and multiple prior sinus surgeries, it is more likely that the septal perforation resulted from surgical trauma, chronic obstructive polyposis, or the chronic use of topical nasal corticosteroids sprays.However, in the opinion of the treating physician, the device contributed to the adverse event, thus intersect ent is reporting this event out of an abundance of caution.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.

Event Description

The patient underwent a revision endoscopic sinus surgery (ess) on (b)(6) 2015; sinus implants were placed bilaterally in the ethmoid sinuses.During a post-surgical follow-up visit on (b)(6) 2015, the physician reported a posterior septal perforation apparent near the deployed implants.The physician reported on (b)(6) 2015 that no intervention was required at this time; she plans to monitor/observe the perforation.(as implants were placed bilaterally, the manufacturer is filing a report for each: please refer to mfr # 3010101669-2016-00001 for report on the other implant).

Event Description

The patient underwent a revision endoscopic sinus surgery (ess) on (b)(6) 2015; sinus implants were placed bilaterally in the ethmoid sinuses.During a post-surgical follow-up visit on (b)(6) 2015 the physician reported a posterior septal perforation apparent near the deployed implants.The physician reported on (b)(6) 2015 that no intervention was required at this time; she plans to monitor/observe the perforation.

• Brand Name: PROPEL MINI SINUS IMPLANT
• Type of Device: DRUG ELUTING 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: 5411863
• MDR Text Key: 37535624
• Report Number: 3010101669-2016-00002
• 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,Followup
• Report Date: 12/10/2015

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: Physician
• Device Expiration Date: 11/26/2016
• Device Model Number: 60011
• Device Catalogue Number: 60011
• Device Lot Number: 50526001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2015
• 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): Disability
• Patient Age: 50 YR