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	Dizziness (2194)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the fourth of 5 records.Subject device remains implanted.
Event or Problem Description
It was reported that approximately 5 month post stent-assisted coil embolization of right internal carotid artery-ophthalmic artery, the patient experienced dizziness that was resolved the same day without residual effect.Mri was done and the patient was referred to follow up at balance center.The physician established that the dizziness was related to the procedure, to the stent, and to coils (subject devices).The patient was assessed neurologically after procedure and at 2 month post-procedure with mrs of 0.At 6 month and 12 month post-procedure, nihss and mrs were 0.
Event or Problem Description
It was reported that approximately 5 month post stent-assisted coil embolization of right internal carotid artery-ophthalmic artery, the patient experienced dizziness that was resolved the same day without residual effect.Mri was done and the patient was referred to follow up at balance center.The physician established that the dizziness was related to the procedure, to the stent, and to coils (subject devices).The patient was assessed neurologically after procedure and at 2 month post-procedure with mrs of 0.At 6 month and 12 month post-procedure, nihss and mrs were 0.
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 sequelae such as dizziness 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.

• 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: 7192157
• Report Number: 3008881809-2018-00037
• Device Sequence Number: 10790881
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: (01)07613252600312(17)180831(10)18554640
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 08/31/2018
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 18554640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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
• Patient Age: 69 YR