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

Catalog Number	M0035421020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm embolization procedure, a first coil (subject coil) was successfully placed in the aneurysm.A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter.During retraction of the second coil, the previously implanted first coil (subject coil) was unintentionally withdrawn from its implanted position within the aneurysm.The physician reported no resistance during the event.There was an approximate 10-minute procedural delay.No additional information is available.
Additional Manufacturer Narrative
This is 3 of 3 mdrs (3rd mdr).

• 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: 50892963
• Report Number: 3008881809-2026-00597
• Device Sequence Number: 17642751
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: (01)04546540697967(17)310504(10)26258077
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035421020
• Device Lot Number: 26258077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2026
• 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: Target coil (stryker).
• Patient Sex: Unknown