MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 5 (coils) reports filed associated with this event.Subject device remains implanted.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the right middle cerebral artery (mca) bifurcation.Post-procedure the patient was assessed having a mrs of 0.It was reported that 9 months post procedure, the patient experienced bilateral weakness.The bilateral weakness was ongoing and a mri procedure was performed showing stable findings consistent with chronic small vessel ischemic white matter change.No infarction was identified.According to the physician, the bilateral weakness was unrelated to the procedure and stents.However it is unknown if the bilateral weakness was related to the implanted coils (subject devices).The patient was assessed having a mrs of 0 at 2, 6 and 12 months and a nihhs of 0 at 12 months post the index procedure.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.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 (bilateral weakness) 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.This is the first of 5 reports filed associated with this event.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an aneurysm located in the right middle cerebral artery (mca) bifurcation.Post-procedure the patient was assessed having a mrs of 0.It was reported that 9 months post procedure, the patient experienced bilateral weakness.The bilateral weakness was ongoing and a mri procedure was performed showing stable findings consistent with chronic small vessel ischemic white matter change.No infarction was identified.According to the physician, the bilateral weakness was unrelated to the procedure and stents.However it is unknown if the bilateral weakness was related to the implanted coils (subject devices).The patient was assessed having a mrs of 0 at 2, 6 and 12 months and a nihhs of 0 at 12 months post the index procedure.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6865514
• Report Number: 3008881809-2017-00324
• Device Sequence Number: 124939
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)181130(10)18700854
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/03/2017

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: 11/20/2018
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 18700854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4 TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR