MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT

Model Number 70011

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

Patient Problem Foreign Body Reaction (1868)

Event Date 12/24/2016

Event Type  Injury  

Manufacturer Narrative

The patient's granulomatous reaction is likely due to a delayed foreign body/allergen-mediated reaction to a component or components of the sinus implant.It is suspect the patient has a previously undiagnosed auto-immune or hypersensitivity disorder.Foreign body reaction is a known risk in patients who are susceptible to this type of reaction.The patients' weight and the lot number(s) of the devices are not known to the manufacturer.The device was not available for evaluation as it was not returned to the manufacturer.Risks associated with the use of this sinus implant are anticipated to be similar to those experienced by patients who undergo placement of other sinus implants or packing.Foreign body reaction may occur as is possible with most surgical adjuncts.The following is being provided as this device is a combination product: name: propel or propel mini (populate as appropriate).Dose, frequency & route used: (1) 370 ug implant.Diagnosis for use: sinus surgery.Combination product -yes.Reference mfr 3008301917-2017-00001 for first implant in the initial event.Reference mfr 3008301917-2017-00003 and mfr 3008301917-2017-00004 for the implants in the subsequent event.

Event Description

On day 1 the patient underwent a sinus procedure during which sinus implants were placed bilaterally in the ethmoid sinuses.Septal splints of unknown manufacturer were also placed bilaterally.No sinus implant device malfunction or patient injury is noted to have occurred during the patient's initial procedure.Day 6, the patient was seen by the surgeon for a routine post-operative visit, at which point the septal splints were removed, and per report, the implants were left in place.At that time, there was mild bleeding upon removal of the splints, and a small amount of inflammatory tissue was present, both were within normal expectations.Two days later, patient presented with epistaxis and was taken back to the or.During that procedure it was noted that the patient had "extensive granulation tissue," a "large blood clot," and a posterior bleed.The surgeon elected to remove the sinus implants and they were replaced bilaterally with new ones.The following night the patient reported having a "big bleed" and was seen by the surgeon in her office the next day.The patient was examined endoscopically and observed that the source of the patient's bleed (the prior night) was near the sphenoid, "extensive granulation tissue around the stents bilaterally and fibrinous middle turbinates adhered to the lateral walls." the physician removed the bilateral implants and debrided the fibrinous tissue encompassing the implants to remove the obstruction of the ethmoid cavity.Patients' event is completely resolved.

Manufacturer Narrative

Corrected data: event description: corrected sinus procedure to surgical sinus procedure, corrected day 6 to day 8, corrected the day the patient reported a "big bleed" from the following night to two days later.Manufacturer narrative: the physician confirmed there was no causal relationship of epistaxis with the sinus implants.

Event Description

On day 1 the patient underwent a surgical sinus procedure during which sinus implants were placed bilaterally in the ethmoid sinuses.Septal splints of unknown manufacturer were also placed bilaterally.No sinus implant device malfunction or patient injury is noted to have occurred during the patient's initial procedure.Day 8, the patient was seen by the surgeon for a routine post-operative visit, at which point the septal splints were removed, and per report, the implants were left in place.At that time, there was mild bleeding upon removal of the splints, and a small amount of inflammatory tissue was present, both were within normal expectations.Two days later, patient presented with epistaxis and was taken back to the or.During that procedure it was noted that the patient had "extensive granulation tissue," a "large blood clot," and a posterior bleed.The surgeon elected to remove the sinus implants and they were replaced bilaterally with new ones.Two days later, the patient reported having a "big bleed" and was seen by the surgeon in her office the next day.The patient was examined endoscopically and observed that the source of the patient's bleed (the prior night) was near the sphenoid, "extensive granulation tissue around the stents bilaterally and fibrinous middle turbinates adhered to the lateral walls." the physician removed the bilateral implants and debrided the fibrinous tissue encompassing the implants to remove the obstruction of the ethmoid cavity.Patients' event is completely resolved.

• Brand Name: PROPEL SINUS IMPLANT
• Type of Device: PROPEL SINUS IMPLANT
• Manufacturer (Section D): INTERSECT ENT; 1555 adams dr; menlo park CA 94025
• 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: 6294942
• MDR Text Key: 66319796
• Report Number: 3008301917-2017-00002
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 70011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 49 YR