MAUDE Adverse Event Report: INTERSECT ENT; DRUG-ELUTING SINUS STENT

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Bacteremia is exceedingly rare in chronic sinusitis.The instructions for use list infection as a potential risk associated with use of the steroid-eluting sinus implant(s).In an abundance of caution, intersect ent is reporting this event as an adverse event based on the information we received and the remote possibility the complication was caused by use of the implant rather than merely correlated with its placement the patient's weight is not known to the manufacturer.Date of the event was approximately 3 ½ weeks post operatively.The physician could not recollect the model of the device used, was either propel (model 70011) or propel mini (model number 60011).The following is being provided as this device is a combination product: name: propel or propel mini, dose, frequency & route used: (1) 370 ug implant, diagnosis for use: sinus surgery.Combination product -yes.Reference mfr report number 3008301917-2017-0007 for first implant in this bilateral case.

Event Description

Patient underwent bilateral total ethmoidectomy and maxillary antrostomy during which bilateral steroid-eluting sinus implants were placed in the ethmoid cavities.Bioresorbable nasal packing product was placed within the implant on each side.No polyps or infection were encountered during surgery.Blood loss was minimal and the surgery was uneventful.Postoperatively, the patient was on oral antibiotics for 10 days and twice daily saline irrigations.Postoperative appointments occurred weekly.The first two appointments were reported to be uneventful and included endoscopy and debridement, the implants were left in place.At the third postoperative appointment, the patient reported feeling poorly.The examining physician noted pus in the sinuses, worse on the right.Cultures were obtained and grew non-resistant staphylococcal species.The patient was started on augmentin.Subsequently, approximately 3 ½ weeks postoperatively, the patient presented to the emergency room and reportedly appeared toxic.A ct was obtained and showed diffuse inflammation in the operated sinuses, but no evidence of orbital wall dehiscence, or paranasal abscess formation.Blood cultures were obtained (eventually grew staphylococcal species), the patient was admitted and placed on iv antibiotics.The patient improved and discharged to home without further medical or surgical intervention.

• Type of Device: DRUG-ELUTING SINUS STENT
• 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: 6659334
• MDR Text Key: 78129972
• Report Number: 3008301917-2017-00008
• 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
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR