MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-24 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[70771393]
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.
Patient Sequence No: 1, Text Type: N, H10
[70771394]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2017-00006 |
| MDR Report Key | 6431483 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-24 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-02-18 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2016-07-07 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMY WOLBECK |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506412115 |
| Manufacturer G1 | INTERSECT ENT |
| Manufacturer Street | 1555 ADAMS DR |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPEL SINUS IMPLANT |
| Generic Name | PROPEL SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2017-03-24 |
| Model Number | 70011 |
| Lot Number | 60707001 |
| Device Expiration Date | 2018-07-07 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | 1555 ADAMS DR MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-03-24 |