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 Scarring (2061)

Event Type  Injury  

Manufacturer Narrative

Attempts were made to contact the physician to request additional details in regard to this event, no response was received.The physician indicated that the patient needs revision surgery; however, it is unknown at this time, whether the patient has had revision surgery or has received any other treatment.Middle turbinate lateralization is a condition that may occur post-sinus surgery and is not likely to cause any detrimental effect in patients.It may impair visualization of the sinus cavity or if more severe may obstruct nasal drainage increasing the chance of sinus infections, however will not impair breathing.Thus, it is not likely that mt lateralization will cause or contribute to permanent impairment of body function or permanent damage to a body structure.The implant is intended to be used in conjunction with standard post-ess care, patient management is at the physician's discretion.Due to the limited information the company is taking a conservative approach in reporting this event.(b)(6).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 endoscopic sinus surgery (ess) including bilateral total full ethmoidectomy, frontal sinusotomy, and inferior turbinate resection, resulting in a significant tissue removal.The sinus implant was placed in the ethmoid sinus bilaterally per instructions for use (ifu).Physician instructed the patient to routinely irrigate.No post-operative visits were scheduled.The patient returned to see the physician 15 days post-operatively.The physician reported that the implant was not present, and the middle turbinate (mt) had scared to the lateral nasal wall bilaterally.The implant might have prematurely migrated and been expelled.The patient has been set up for revision surgery.(refer to mfr report # 3010101669-2015-00005 for other implant).

• 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: 5039788
• MDR Text Key: 24516256
• Report Number: 3010101669-2015-00004
• Device Sequence Number: 1
• Product Code: OWO
• UDI-Device Identifier: M927700110
• UDI-Public: +M927700110
• 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
• Report Date: 08/02/2015

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: 10/09/2016
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 50409004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2015
• 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): Other