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 2016-09-26 for PROPEL MINI SINUS IMPLANT 60011 manufactured by Intersect Ent.
[55679276]
The age and weight of the patient is not known. Physician noted the patient had previously undergone a sinus surgery consisting of ethmoidectomy, uncinectomy, turbinate reduction, maxillary antrostomy and frontal sinusotomy (date unknown). No implants were used in the initial surgery. The patient continued to complain of frontal headaches after her surgery (time period unknown). The physician took the patient to the or for a revision surgery. The device was not available for evaluation as it was not returned to the manufacturer. The delivery system appeared to have operated as intended, as the implant was deployed successfully. The lot history record review was completed and confirmed that the lot met release specifications. Risks associated with the use of this sinus implant are anticipated to be similar to those experienced by patients who undergo placement of sinus implants or packing. Manifestation of a csf leak is a potential surgical complication and may occur inadvertently due to the insertion of any surgical instrument. It is unknown whether the patient had any anatomical abnormalities that may have pre-disposed them for a csf leak. If additional information is received regarding this report, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[55679277]
The physician reported a csf leak following sinus surgery. The surgery was a bilateral revision procedure completed in the operating room (or). The frontal and sphenoid sinus openings were accessed, and dilated using a balloon catheter system, and a sinus implant was placed in the left frontal sinus opening. Due to the patients' anatomy the initial attempt to deploy the sinus implant into the right frontal sinus opening was not successful. The delivery system was withdrawn and re-advanced. While advancing the delivery system the second time, the physician encountered some resistance and reported hearing and feeling a crack. He proceeded to successfully deploy the sinus implant, and after removing the delivery system, observed via endoscope, what he believed was a csf leak on the right side. The physician explanted the right side implant (left side implant remained in place) and repaired the leak. In the physician's opinion the implant itself is too soft to cause trauma, and he believes the csf leak was caused by insertion of the delivery system. On a post-op ct scan, a 5 mm pneumocephalus with blood in subarachnoid space was observed. The patient was transferred to another facility with neurosurgical coverage. The patient seemed to be doing fine except for severe headache. At the time of this report, neurosurgery was considering placing a lumbar drain and there was a possibility that she might require additional surgery to close the csf leak if the lumbar drain was unsuccessful. After several attempts the manufacturer has been unable to obtain any additional information on the patients' current status.
Patient Sequence No: 1, Text Type: D, B5
[58157967]
Correction to lot number. Initial report (604015001) contained a typo. Should have read 60405001.
Patient Sequence No: 1, Text Type: N, H10
[58157968]
The physician reported a csf leak following sinus surgery. The surgery was a bilateral revision procedure completed in the or. The frontal and sphenoid sinus openings were accessed, and dilated using a balloon catheter system, and a sinus implant was placed in the left frontal sinus opening. Due to the patients' anatomy the initial attempt to deploy the sinus implant into the right frontal sinus opening was not successful. The delivery system was withdrawn and re-advanced. While advancing the delivery system the second time, the physician encountered some resistance and reported hearing and feeling a crack. He proceeded to successfully deploy the sinus implant, and after removing the delivery system, observed via endoscope, what he believed was a csf leak on the right side. The physician explanted the right side implant (left side implant remained in place) and repaired the leak. In the physician's opinion the implant itself is too soft to cause trauma, and he believes the csf leak was caused by insertion of the delivery system. On a post-op ct scan, a 5 mm pneumocephalus with blood in subarachnoid space was observed. The patient was transferred to another facility with neurosurgical coverage. The patient seemed to be doing fine except for severe headache. At the time of this report, neurosurgery was considering placing a lumbar drain and there was a possibility that she might require additional surgery to close the csf leak if the lumbar drain was unsuccessful. After several attempts the manufacturer has been unable to obtain any additional information on the patients' current status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008301917-2016-00005 |
| MDR Report Key | 5978861 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-26 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-29 |
| Date Mfgr Received | 2016-10-13 |
| Device Manufacturer Date | 2016-04-05 |
| Date Added to Maude | 2016-09-26 |
| 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 MINI SINUS IMPLANT |
| Generic Name | PROPEL MINI SINUS IMPLANT |
| Product Code | OWO |
| Date Received | 2016-09-26 |
| Model Number | 60011 |
| Catalog Number | 60011 |
| Lot Number | 60405001 |
| Device Expiration Date | 2018-04-05 |
| 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 | 6 | 1. Hospitalization; 2. Required No Informationntervention | 2016-09-26 |