MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	04/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the fifth of 10 reports filed associated with this event.Subject device remains implanted.
Event or Problem Description
The patient underwent successful stent-assisted coil embolization of an un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils (subject devices) and access devices.No further information is available.
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, headache 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 un-ruptured aneurysm located in the internal carotid artery-posterior communicating artery.On the day of the procedure, the patient experienced a first headache.The first headache was resolved the next day with no residual effects.Two days post-procedure, the patient experienced a second headache.The second headache was ongoing.Medication was administered to treat the headache (2mg dexamethasone and 1 mg morphine and 650 mg acetaminophen).Post procedure, at 2-month, 6-month, and 12-month post-procedure the patient was neurologically assessed having a modified rankin scale (mrs) of 1.At 2-month, 6-month, and 12-month post-procedure the patient was assessed having a national institutes of health stroke scale (nihss) of 2.The physician has indicated that the 2 events of headache were possibly related to the index procedure and to the stent and not related to pre-existing condition/co-morbidity.However, it is unknown if the headache was related to the implanted coils (subject devices) and access devices.No further information is available.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6929156
• Report Number: 3008881809-2017-00404
• Device Sequence Number: 1312995
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)181130(10)18730918
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• 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): 12/06/2017

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: 11/30/2018
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 18730918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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: 58 YR