MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET 360 ULTRA 2.5MM X 4CM; Device, Neurovascular Embolization

Catalog Number	M0035422540
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); 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 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placed in the aneurysm.A second coil was subsequently introduced but was determined not to be a suitable fit and was retracted into the microcatheter.During retraction of the second coil, the first subject coil was unintentionally retracted from its implanted position.The physician reported no resistance during the event.Additional coil placement was subsequently attempted.The event resulted in an approximate 10-minute procedural delay.Additional coil placement was subsequently attempted, after which the aneurysm ruptured.The patient was transferred to neurosurgery for clipping.The physician reported that the patient was not expected to survive.No additional information is available.Update: additional information received on 16-sept-2026 confirmed that an aneurysm rupture was reported in association with the subject coil (third coil).The aneurysm rupture occurred during the attempt to place the subject coil.The patient was transferred to neurosurgery for clipping.The physician reported that the patient was not expected to survive.The event resulted in an approximate 10-minute procedural delay.No additional information is available.
Additional Manufacturer Narrative
This is 1 of 3 mdrs (1st mdr).B1 product problem - updated.B2 ¿ outcomes attributed to ae - updated.B5 executive summary - updated.D1-product long description-updated.D4 ¿ catalog# - corrected.D4 ¿ lot # added.D4- expiration date- added.D4-gtin-added.H1 type of reportable event ¿ updated.H4-manufacturing date- added.F10 / h6 medical device problem code - device code grid ¿ corrected.F10 / h6 health effect - clinical code - clinical signs code grid ¿ corrected.F10 / h6 health effect - impact code - health impact code grid - corrected.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• 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: 50434982
• Report Number: 3008881809-2026-00530
• Device Sequence Number: 10397902
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: (01)04546540675866(17)301129(10)25998664
• Combination Product (Y/N): N
• 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,Followup
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0035422540
• Device Lot Number: 25998664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/14/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown