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

Catalog Number	M0035422540
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aneurysm embolization procedure, a first coil was placed in the aneurysm.A second coil was determined not to be a good fit and was retracted into the microcatheter.During retraction, the first coil was also retracted.The physician reported that no resistance was encountered.A new subject coil was then attempted, after which the aneurysm ruptured.The consultant stated that the aneurysm rupture was caused by the coil.The event resulted in a 10-minute surgical delay.The patient was subsequently transferred to the neurosurgery department for clipping.The consultant stated that the patient would most likely not survive.No additional information available.
Event or Problem Description
It was reported that during an aneurysm embolization procedure, a first coil was placed in the aneurysm.A second coil was determined not to be a good fit and was retracted into the microcatheter.During retraction, the first coil was also retracted.The physician reported that no resistance was encountered.A new subject coil was then attempted, after which the aneurysm ruptured.The consultant stated that the aneurysm rupture was caused by the coil.The event resulted in a 10-minute surgical delay.The patient was subsequently transferred to the neurosurgery department for clipping.The consultant stated that the patient would most likely not survive.No additional information available.Update: additional information received on 16-sept-2026 confirmed that the subject coil (lot #26156878) did not cause the aneurysm rupture.It was reported that the subject coil was not a good fit and was retracted.The event resulted in an approximate 10-minute procedural delay.No additional information is available.
Additional Manufacturer Narrative
This is 2 of 2 mdrs (2nd mdr).
Additional Manufacturer Narrative
This is 2 of 3 mdrs (2nd mdr).B1 product problem - corrected - no adverse event.B2 ¿ outcomes attributed to ae - corrected - no hospitalization-initial or prolonged, no other serious (important medical events), and no required intervention to prevent permanent impairment/damage (devices), h1 type of reportable event ¿ corrected - no serious injury.B5 executive summary - updated.D1-product long description-updated.D4 ¿ catalog# - corrected.D4 ¿ lot # added.D4- expiration date- added.D4-gtin-added.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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• 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: 50434978
• Report Number: 3008881809-2026-00529
• Device Sequence Number: 10397899
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: (01)04546540675866(17)310224(10)26156878
• 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: 26156878
• 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: 02/26/2026
• 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)
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown