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 2017-02-01 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[66316126]
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 adjucts. 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 3008301917-2017-00002 for second implant in the initial event. Reference mfr 3008301917-2017-00003 and mfr 3008301917-2017-00004 for the implants in the subsequent event.
Patient Sequence No: 1, Text Type: N, H10
[66316127]
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.
Patient Sequence No: 1, Text Type: D, B5
[68784784]
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.
Patient Sequence No: 1, Text Type: N, H10
[68784785]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2017-00001 |
| MDR Report Key | 6294938 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-02-01 |
| Date of Report | 2017-01-05 |
| Date of Event | 2016-12-24 |
| Date Mfgr Received | 2017-02-08 |
| Date Added to Maude | 2017-02-01 |
| 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 | 2017-02-01 |
| Model Number | 70011 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2017-02-01 |