MAUDE Adverse Event Report: INTERSECT ENT PROPEL MINI SINUS IMPLANT

Model Number 60011

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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attempt to deploy the sinus implant into the right frontal sinus opening was not successful.The delivery system was withdrawn and re-advanced.While advancing the delivery system the second time, the physician encountered some resistance and reported hearing and feeling a crack.He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.

Manufacturer Narrative

Correction to lot number.Initial report (604015001) contained a typo.Should have read 60405001.

Event Description

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.

• Brand Name: PROPEL MINI SINUS IMPLANT
• Type of Device: PROPEL MINI SINUS IMPLANT
• 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: 5978861
• MDR Text Key: 55679276
• Report Number: 3008301917-2016-00005
• Device Sequence Number: 1
• Product Code: OWO
• UDI-Device Identifier: M927600110
• UDI-Public: +M927600110
• 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,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/05/2018
• Device Model Number: 60011
• Device Catalogue Number: 60011
• Device Lot Number: 60405001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• 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
• Treatment: 6 MM ENTELLUS BALLOON
• Patient Outcome(s): Hospitalization; Required Intervention