MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number N/A

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

Patient Problems Eye Injury (1845); Swelling (2091); Visual Impairment (2138)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Acclarent products were used during the procedure, along with traditional surgical instruments (unknown type).The physician noted that he believed "a blood vessel may have retracted from the sinus space into the orbit which lead to bleeding as a result of the ethmoidectomy performed." the physician also noted that he does not believe the balloon lead to the swelling.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.If additional information is received regarding this report, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was informed of an event in which a patient was said to have developed a swollen eye, double vision (diplopia), and the inability to move the eye following a hybrid procedure involving a total ethmoidectomy and balloon sinuplasty of the maxillary sinuses.An acclarent relieva spin 6x16 sinuplasty system was said to have been used along with unknown types of rigid traditional surgical instruments during the procedure, which was performed on (b)(6) 2015.The surgeon reported that the balloon sinuplasty portion of the surgery went as planned with no complications.Approximately 45 minutes following the procedure, the patient was said to have developed swelling over the left orbit.Ice compression was administered, and a fast-acting diuretic was given to the patient to reduce the orbital swelling.No additional treatment was given, and the swelling was reduced.A post-operative ct scan was not done at the time, and the patient was referred to an optometrist.It was reported that the optometrist found that the patient had normal visual acuity, however there was no movement for the eye.Additional information obtained noted that the patient was also experiencing diplopia, starting on an unknown date after surgery.One week post-op, the patient was reported to still be experiencing no eye movement.A post-op ct scan performed on an unknown date was reported to have shown no dehiscence of the sinus or orbital walls.The patient was referred to an ophthalmologist.It was later reported that, as of (b)(6) 2015, there has been no change in the patient's condition, the diplopia was still present, and the medial rectus muscle was not functioning.The patient was said to have been referred to the mayo clinic eye program.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o¿brien dr; menlo park CA
• Manufacturer Contact: izabel nielson ; 1525-b o¿brien dr.; menlo park, CA 94025 ; 6506877492
• MDR Report Key: 5078094
• MDR Text Key: 25831221
• Report Number: 3005172759-2015-00012
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RS0616MFS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RIGID TRADITIONAL SURGICAL INSTRUMENTS
• Patient Outcome(s): Required Intervention; Disability