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 2015-08-28 for PROPEL SINUS IMPLANT 70011 manufactured by Intersect Ent.
[24516256]
Attempts were made to contact the physician to request additional details in regard to this event, no response was received. The physician indicated that the patient needs revision surgery; however, it is unknown at this time, whether the patient has had revision surgery or has received any other treatment. Middle turbinate lateralization is a condition that may occur post-sinus surgery and is not likely to cause any detrimental effect in patients. It may impair visualization of the sinus cavity or if more severe may obstruct nasal drainage increasing the chance of sinus infections, however will not impair breathing. Thus, it is not likely that mt lateralization will cause or contribute to permanent impairment of body function or permanent damage to a body structure. The implant is intended to be used in conjunction with standard post-ess care, patient management is at the physician's discretion. Due to the limited information the company is taking a conservative approach in reporting this event. (b)(6). 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.
Patient Sequence No: 1, Text Type: N, H10
[24516257]
The patient underwent endoscopic sinus surgery (ess) including bilateral total full ethmoidectomy, frontal sinusotomy, and inferior turbinate resection, resulting in a significant tissue removal. The sinus implant was placed in the ethmoid sinus bilaterally per instructions for use (ifu). Physician instructed the patient to routinely irrigate. No post-operative visits were scheduled. The patient returned to see the physician 15 days post-operatively. The physician reported that the implant was not present, and the middle turbinate (mt) had scared to the lateral nasal wall bilaterally. The implant might have prematurely migrated and been expelled. The patient has been set up for revision surgery. (refer to mfr report # 3010101669-2015-00005 for other implant)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010101669-2015-00004 |
| MDR Report Key | 5039788 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-28 |
| Date of Report | 2015-08-02 |
| Date Mfgr Received | 2015-08-02 |
| Device Manufacturer Date | 2015-04-09 |
| Date Added to Maude | 2015-08-28 |
| 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 | DRUG ELUTING SINUS STENT |
| Product Code | OWO |
| Date Received | 2015-08-28 |
| Model Number | 70011 |
| Catalog Number | 70011 |
| Lot Number | 50409004 |
| Device Expiration Date | 2016-10-09 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSECT ENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-28 |