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	Headache (1880)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 4th of 12 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 basilar artery apex.Post-procedure, the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that a day post-procedure, the patient experienced headache.The headache was resolved within one month post-procedure.The patient¿s headache was treated with medrol dose pack, iv fluids (1000 ml), iv hydromorphine (1 mg), iv dexamethasone (6mg).According to the physician, the headache was possibly related to the procedure and stent.However, it is unknown if the headache was related to the implanted coils (subject device) and access devices.During the 2 months follow-up, the patient was assessed having a mrs of 0.At the 6 months follow up post the index procedure, the patient was assessed having a nihhs and mrs of 0.In addition, during the 6 months visit, the patient was still taking excedrine for migraine history.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.The additional information states that the patient had headache and migraine history and that all devices used in the procedure performed as intended.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 aneurysm located in the basilar artery apex.Post-procedure the patient was assessed having a modified ranking scale (mrs) of 0.It was reported that a day post-procedure, the patient experienced headache.The headache was resolved within one month post-procedure.The patient¿s headache was treated with medrol dose pack, iv fluids (1000 ml), iv hydromorphine (1 mg), iv dexamethasone (6mg).According to the physician, the headache was possibly related to the procedure and stent.However, it is unknown if the headache was related to the implanted coils (subject device) and access devices.During the 2 months follow-up, the patient was assessed having a mrs of 0.At the 6 months follow up post the index procedure, the patient was assessed having a nihhs and mrs of 0.In addition, during the 6 months visit, the patient was still taking excedrine for migraine history.No further information is available.

• 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: 6863993
• Report Number: 3008881809-2017-00309
• Device Sequence Number: 13631419
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)190731(10)19198070
• 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): 10/31/2017

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: 07/31/2019
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 19198070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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: 2 EXCELSIOR SL-10 MICROCATHETER (STRYKER); 2 NEUROFORM ATLAS STENT (STRYKER); 2 SYNCHRO GUIDEWIRE (STRYKER); 7 TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR