MAUDE Adverse Event Report: INTERSECT ENT INC. PROPEL CONTOUR SINUS IMPLANT; DRUG-ELUTING NASAL STENT

Model Number 50011 - 70033

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

Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

On 22sep2020 intersect ent received a complaint that a (b)(6) y/o caucasian male patient received bilateral propel contour implants in the frontal sinus opening following frontal sinus balloon angioplasty.During the recovery period, the patient had a vasovagal response due to low blood pressure.Ems was called and the patient was taken to the hospital to be evaluated.On 24sep2020 the site was contacted for follow-up.The implanting physician's assistant provided the following details: the patient was sitting when he had the vasovagal syncope episode.He was out approximately 2 minutes prior to emergency medical services (ems) arriving.Ice packs were placed on patient's forehead/back of neck for comfort.Heart rate and oxygen level were monitored until ems arrived.Ems transported the patient to the hospital, where he was admitted for vasovagal syncope/ bradycardia.The patient has a pre-existing history of vasovagal syncope.Medical history includes: sinusitis, obstructive sleep apnea, deviated septum, fatigue, gerd, vitamin d deficiency, djd, hyperlipidemia, bruxism, endoscopic sinus surgery, prior tobacco use.Allergies: nkda, no known drug allergies meds: cefdinir, pantoprazole, naproxen prn, vitamin d.Patient had been instructed by the physician's office to take one percocet pre-procedure, which he did.The pa commented that the implanting physician did not believe the propel contour implants caused the vasovagal syncopal episode.On 25sep2020 the site was contacted with a request for additional information on when patient was discharged, treatment in the hospital, and outcome.Site is waiting to hear back from the wife.Site has not heard back from wife and the assistant did not feel comfortable contacting the wife.Intersect ent remarks: intersect ent is a combination product manufacturer and complies with post market safety reporting (pmsr) final rule for combination product manufacturers, effective from 31 july, 2020.Lots involved in the incident: contour, lot 91113002, exp.11/13/2021, date of mfr: 11/13/2019.Contour, lot 00220002, exp.02/20/2022, date of mfr: 02/20/2020.The reported event is deemed serious due to inpatient hospitalization.The event is also not listed in propel contour ifu.Under pmsr final rule intersect ent deemed this report as reportable to fda.The incidence of vasovagal response during a rhinologic procedures is low.* based upon the patient having a pre-existing condition of vasovagal syncope, this episode probably was not related to the propel contour device and/or procedure.Without additional information (admission, treatment and discharge), a determination of causality cannot be made at this time.Radvansky bm, husain q, cherla dv, choudhry oj, eloy ja.In-office vasovagal response after rhinologic manipulation.Int forum allergy rhinol.2013 jun;3(6):510-4.Doi: 10.1002/alr.21121.Epub 2012 nov 28.Pmid: 23193039.

Event Description

On (b)(6) 2020, post procedure (balloon sinuplasty, two proprel contour stents placed in the frontal sinuses) the patient had a vasovagal response during recovery due to low blood pressure.Ems was called for the patient.Company sales rep was present for the procedure, but not during recovery when the event occurred.Company sales rep followed up with the clinic later that day to learn that the patient left via ems.At the time of the initial report to intersect ent, there was no update on the patient status.The company sales rep communicated on 01oct2020 via email that no new information was obtained after speaking with the implanting physician.

• Brand Name: PROPEL CONTOUR SINUS IMPLANT
• Type of Device: DRUG-ELUTING NASAL STENT
• Manufacturer (Section D): INTERSECT ENT INC.; 1555 adams dr; menlo park 94025
• Manufacturer (Section G): INTERSECT ENT, INC.; 1555 adams dr; menlo park CA 94025
• Manufacturer Contact: antoinette douglas ; 1555 adams dr; menlo park, CA 94025 ; 6507887928
• MDR Report Key: 10723115
• MDR Text Key: 212717276
• Report Number: 3008301917-2020-00001
• Device Sequence Number: 1
• Product Code: OWO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100044
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 50011 - 70033
• Device Lot Number: 91113002, 00220002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• 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
• Treatment: CEFDINIR; NAPROXEN PRN; PANTOPRAZOLE; PERCOCET 1 TABLET PRIOR TO PROCEDURE; VITAMIN D
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR