MAUDE Adverse Event Report: INTERSECT ENT PROPEL SINUS IMPLANT

Model Number 70011

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Date 02/18/2017

Event Type  Injury  

Manufacturer Narrative

The patient denied any previous drug allergies pre-operatively and upon presentation with symptoms postoperatively, denied being allergic to mometasone furoate (nasonex).However, the patient subsequently remembered that he had previously experienced edema when using nasonex.Based on the clinical presentation, the resolution of the symptoms upon removal of the implants and the additional medical history indicative of an allergy to mometasone furoate, it is the treating physician's medical opinion that the patient suffered an allergic reaction to the mometasone furoate on the surface of the implants.The instructions for use states that the use of the sinus implant is contraindicated in patients with suspected or confirmed intolerance to mometasone furoate.The patient's weight is not known to the manufacturer.The device was not available for evaluation as it was not returned to the manufacturer.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.Reference 3008301917-2017-00005 for first implant of bilateral case.

Event Description

Patient underwent revision sinus surgery which included bilateral total ethmoidectomy and maxillary antrostomy followed by placement of 1 drug-eluting sinus implant into each ethmoid sinus.Patient presented post op day 3 and 4 with bilateral periorbital edema, severe pain and blurred vision.Post op day 4 ct scan conducted showed no damage to orbit and no infections.Based on the clinical picture, negative ct scan and physical exam findings, the physician concluded that the most likely cause of the patient's symptoms was an allergic reaction to the implants and removed both.The patient's bilateral ocular edema was significantly reduced within 2 hours of the removal.The physician reports during his follow-up visit, the patients' symptoms were completely resolved.

Manufacturer Narrative

Correction to describe event or problem (b5) initial report -the patient's bilateral occular edema was significantly reduced within 2 hours of removal.Corrected report description - the patient's bilateral periorbital edema was significantly reduced within 2 hours of removal.Additionally clarified the allergic reaction to the implants was to the mometasone furoate on the surface of the implants.Reference 3008301917-2017-00005 for first implant of bilateral case.

Event Description

Patient underwent revision sinus surgery which included bilateral total ethmoidectomy and maxillary antrostomy followed by placement of 1 drug-eluting sinus implant into each ethmoid sinus.Patient presented post op day 3 and 4 with bi-lateral periorbital edema, severe pain and blurred vision.Post op day 4 ct scan conducted showed no damage to orbit and no infections.Based on the clinical picture, negative ct scan and physical exam findings, the physician concluded that the most likely cause of the patient's symptoms was an allergic reaction to the mometasone furoate on the suface of the implants and removed both.The patient's bilateral periorbital edema was significantly reduced within 2 hours of removal.The physician reports during his follow-up visit, the patients' symptoms were 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
• MDR Report Key: 6431483
• MDR Text Key: 70771393
• Report Number: 3008301917-2017-00006
• Device Sequence Number: 1
• Product Code: OWO
• UDI-Device Identifier: M927700110
• UDI-Public: +M927700110
• Combination Product (y/n): N
• PMA/PMN Number: P100044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

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: 07/07/2018
• Device Model Number: 70011
• Device Lot Number: 60707001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: 02/22/2017
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 34 YR