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 Choking (2464)

Event Type  malfunction  

Manufacturer Narrative

The physician stated the implant was placed correctly, however the patient's anatomy may have contributed to the migration.In an abundance of caution, intersect ent is reporting this event as a malfunction based on the information received and the remote possibility of a serious injury should a similar event occur.(b)(4).

Event Description

The patient underwent revision endoscopic sinus surgery (ess) in (b)(6) 2016.Sinus implants were placed bilaterally, in previously modified anatomy, in the ethmoid sinuses without incident.Approximately one week post-surgery the implant on the right side had migrated to the patient's throat area; the left side implant remained in place.The patient felt something in their throat (described as a choking sensation) and concerned about a possible obstruction of the airway went to the er.The reporting physician stated that the patient coughed out the implant prior to receiving intervention while in the er; patient is fine.

Manufacturer Narrative

Voluntary event report (mw 5060385) which contained additional information was received on 3/24/2016.Additional narrative: the information provided in the initial report indicated that the patient visited er.Clinical quality, safety & risk specialist from the hospital confirmed the patient did not mention an er visit when reporting the event to them.Additionally, the hospital had no record of the patient receiving treatment in their er.Based on the lhr review, the product met all specifications.A potential root cause related to manufacturing / process control could not be identified.

Event Description

The patient underwent revision endoscopic sinus surgery (ess) (b)(6) 2015.Sinus implants were placed bilaterally, in previously modified anatomy, in the ethmoid sinuses without incident.Approximately one week post-surgery while the patient was driving, the implant on the right side had migrated to the patient's throat area; the left side implant remained in place.The patient reported to the hospital that he pulled off the freeway and removed the object from his throat manually and then proceeded to drive on to their post-operative appointment with the physician.Patient is 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: 5490510
• MDR Text Key: 40031806
• Report Number: 3010101669-2016-00003
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/28/2017
• Device Model Number: 70011
• Device Catalogue Number: 70011
• Device Lot Number: 50828001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2015
• 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