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

Catalog Number M0035442030

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

Patient Problem Visual Disturbances (2140)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

This is the third of 3 reports.Previous reports have been filed for the same patient: mfr report # 3008881809-2018-00044; mfr report # 3008881809-2018-00045; mfr report # 3008881809-2017-00441; mfr report # 3008881809-2017-00440.Subject device remains implanted.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the left superior cerebellar artery.Post procedure the patient was neurologically assessed having a nihss of 0 and a mrs of 1.Six month post-procedure, the patient experienced diplopia that was resolved the next day without residual effect.No treatment was required.According to the physician, the diplopia was possibly related to the procedure and the stent.However it is unknown if the diplopia was related to the 2nd implanted coil (subject device).The patient was neurologically assessed at 2 and 6 month post procedure having a nihss of 0 and a mrs of 1.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, neurological sequelae like diplopia is a known risk associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.

Event Description

The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the left superior cerebellar artery.Post procedure the patient was neurologically assessed having a nihss of 0 and a mrs of 1.Six month post-procedure, the patient experienced diplopia that was resolved the next day without residual effect.No treatment was required.According to the physician, the diplopia was possibly related to the procedure and the stent.However it is unknown if the diplopia was related to the 2nd implanted coil (subject device).The patient was neurologically assessed at 2 and 6 month post procedure having a nihss of 0 and a mrs of 1.

• Brand Name: TARGET 360 NANO 2 MM X 3 CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7441643
• MDR Text Key: 105874142
• Report Number: 3008881809-2018-00176
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M0035442030
• Device Lot Number: 19621521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ATLAS STENT (STRYKER); TARGET COIL (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 62 YR