MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	05/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event reported for the subject device was also reported for another coil (target 360 ultra 3mm x 6cm) used during the procedure.It is unknown at this time which of the 2 coils was related to the adverse event.Device remains implanted.
Event or Problem Description
It was reported that during stent assisted coil embolization of the anterior communicating artery (acom) aneurysm, a thrombus on the coil was noted at the acom with slow flow at the a2 segment of the anterior cerebral artery (aca).Platelet aggregation inhibitor and anticoagulant medication were given to the patient.The adverse event was resolved without residual effects.The adverse event was related to the coil and to the procedure.
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, patient thrombosis in untreated vessel 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
It was reported that during stent assisted coil embolization of the anterior communicating artery (acom) aneurysm, a thrombus on the coil was noted at the acom with slow flow at the a2 segment of the anterior cerebral artery (aca).Platelet aggregation inhibitor and anticoagulant medication were given to the patient.The adverse event was resolved without residual effects.The adverse event was related to the coil and to the procedure.

• Brand Name: TARGET 360 NANO 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5724337
• Report Number: 3008881809-2016-00033
• Device Sequence Number: 10918221
• Product Code: HCG
• UDI-Device Identifier: 07613252600305
• UDI-Public: (01)07613252600305(17)190228(10)18870085
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/17/2016

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: 02/28/2019
• Device Catalogue Number: M0035442540
• Device Lot Number: 18870085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 08/19/2016
• 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; Required Intervention
• Patient Age: 50 YR