MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 12 emdr filed for this event (10 coils and 2 microcatheters).The subject coil remains implanted.
Event or Problem Description
It was reported that during the stent assisted coil embolization of the un-ruptured aneurysm, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0 and the aneurysm occlusion status was assessed as 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils (subject device) and microcatheters.During patient follow up visits at 2 and 6 months post the index procedure, the patient was assessed having a mrs of 0.No further information is available.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device remains implanted; therefore, physical as well as a functional evaluation could not be performed.However, headache is a known risk associated with endovascular procedures and is noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
It was reported that during the stent assisted coil embolization of the un-ruptured aneurysm, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0 and the aneurysm occlusion status was assessed as 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils (subject device) and microcatheters.During patient follow up visits at 2 and 6 months post the index procedure, the patient was assessed having a mrs of 0.No further information is available.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6939378
• Report Number: 3008881809-2017-00426
• Device Sequence Number: 891989
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: (01)04546540675842(17)180930(10)18600097
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102672
• 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): 12/04/2017

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: 09/30/2018
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 18600097
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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
• Patient Age: 55 YR