MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombus (2101)
Date of Event	12/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a coil embolization procedure, the physician experienced difficulty in placing the coil (subject device) and a stroke occurred followed by a thrombus formation inside the patient vessel.The physician used a microcatheter to remove the thrombus and ended the procedure.The patient was reported to be in stable condition.No further information is available.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the coil delivery wire was kinked, likely due to handling.The main coil was stretched as well.During functional testing, the coil was advanced through the introducer sheath with no issues.Patient stroke and thrombosis formation are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu); therefore, anticipated in nature.Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
It was reported that during a coil embolization procedure, the physician experienced difficulty in placing the coil (subject device) and a stroke occurred followed by a thrombus formation inside the patient vessel.The physician used a microcatheter to remove the thrombus and ended the procedure.The patient was reported to be in stable condition.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: 8286293
• Report Number: 3008881809-2019-00034
• Device Sequence Number: 1448478
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 06/09/2021
• Device Catalogue Number: M0035421520
• Device Lot Number: 20611099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: MICROCATHETER(PENUMBRA); MICROCATHETER(PENUMBRA)
• Outcome Attributed to Adverse Event: Other; Required Intervention