MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET 360 NANO 1MM X 2CM; Device, Neurovascular Embolization

Catalog Number	M0035421020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure for a small approximately 2 mm blister posterior communicating artery aneurysm and a wide neck internal carotid artery (ica)-t aneurysm, the physician decided to treat the smaller aneurysm.After unsuccessful attempts with two coils, the physician attempted to implant the subject coil.Even after detachment of the subject coil, it was perceived that the tip of the subject coil was still inside the microcatheter and not fully detached.Thus, a stent was deployed to cover both the aneurysms and also to tack the coil and microcatheter against the vessel wall.The physician then pulled the microcatheter leaving the subject coil detached and implanted inside the aneurysm.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 15 min due to the reported event.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• Common Device Name: Device, Neurovascular Embolization
• Manufacturer (Section D): Stryker Neurovascular Cork; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): Stryker Neurovascular Cork; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; +1(510)413-2500
• MDR Report Key: 50102860
• Report Number: 3008881809-2026-00483
• Device Sequence Number: 13274638
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: (01)04546540697967(17)310323(10)26201868
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242243
• 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
• Report Date (Section B): 07/31/2026

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 Catalogue Number: M0035421020
• Device Lot Number: 26201868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Excelsior SL-10 microcatheter (Stryker).; Neuroform Atlas Stent (Stryker).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown