MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	05/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 2nd of 3 (coils) reports filed associated with this event.Subject devices remain implanted.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the basilar artery apex.The patient was neurologically assessed as having post-procedure a mrs of 1 and nihss 0.It was reported that 5-day post-procedure the patient noticed a bright "jelly" type light in both eyes.The adverse even was resolved without residual effects.Ten days post-procedure, the patient reported a similar episode of visual disturbance in the left eye described as a bright light at the bottom of her visual field that lasted for 5 minutes.Mri was undertaken and mri impression were negative (no intracranial arterial stenosis or infarction identified).According to the physician, the visual disturbance was probably related to the procedure, stent, and unknown if related to the implanted coils (subject devices).The patient was neurologically assessed as having a mrs of 0 at 2-months, a nihss and mrs of 0 at 6 and 12 months follow-up post the index procedure.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However,neurological/intracranial sequelae (visual disturbances) is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the basilar artery apex.The patient was neurologically assessed as having post-procedure a mrs of 1 and nihss 0.It was reported that 5-day post-procedure the patient noticed a bright "jelly" type light in both eyes.The adverse even was resolved without residual effects.10 days post-procedure, the patient reported a similar episode of visual disturbance in the left eye described as a bright light at the bottom of her visual field that lasted for 5 minutes.Mri was undertaken and mri impression were negative (no intracranial arterial stenosis or infarction identified).According to the physician, the visual disturbance was probably related to the procedure, stent, and unknown if related to the implanted coils (subject devices).The patient was neurologically assessed as having a mrs of 0 at 2-months, a nihss and mrs of 0 at 6 and 12 months follow-up post the index procedure.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6850742
• Report Number: 3008881809-2017-00295
• Device Sequence Number: 65238
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: (01)07613252600312(17)190228(10)18897814
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 18897814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR