MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject coil was used during the coil embolization of anterior communicating artery (acoma) ruptured aneurysm.The subject coil got prematurely detached and made the microcatheter out of control and remained about 10 cm in the microcatheter.The subject coil was then pushed out of microcatheter using a guidewire and a stent was used to push the subject coil up into the aneurysm.There was a surgical delay of 60 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that during the coil embolization of anterior communicating (a-com) ruptured aneurysm, the subject coil was prematurely detached.The coil was repositioned many times and detached partially in the aneurysm, part in the microcatheter.A microcatheter was being used.The coil was pushed out using a guidewire and an adjunctive stent was deployed.The coil appears to have been used in accordance with the dfu.No resistance was noted while advancing the coil.The anatomy was noted to be severely tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that the subject coil was used during the coil embolization of anterior communicating artery (acoma) ruptured aneurysm.The subject coil got prematurely detached and made the microcatheter out of control and remained about 10 cm in the microcatheter.The subject coil was then pushed out of microcatheter using a guidewire and a stent was used to push the subject coil up into the aneurysm.There was a surgical delay of 60 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 4MM X 15CM
• 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 ; 5104132500
• MDR Report Key: 23578443
• Report Number: 3008881809-2025-00638
• Device Sequence Number: 18552017
• Product Code: HCG
• UDI-Device Identifier: 04546540675941
• UDI-Public: (01)04546540675941(17)290906(10)25106535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035424150
• Device Lot Number: 25106535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2024
• 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: ATLAS STENT (STRYKER).; CHIKAI BLACK GUIDEWIRE (ASAHI INTECC MEDICAL).; EXCELSIOR SL-10 (STRYKER).; GREACH MICROCATHETER (TOKAI MEDICAL).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female