MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035476300
Medical Device Problem Codes	Fracture (1260); Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil (subject device) was used in the procedure.However, it was noted that the packaging of the subject coil was damaged.Also, when the coil was halfway assembled in the aneurysm it got prematurely detached.The physician decided to remove the coil and a snare was used to remove the coil, however once the snare was placed the coil partially protruded from the target location; thus, the physician implanted another stent to press the remaining coil against artery wall, only half of the coil could be removed.No further information available.
Event or Problem Description
It was reported that the coil (subject device) was used in the procedure.However, it was noted that the packaging of the subject coil was damaged.Also, when the coil was halfway assembled in the aneurysm it got prematurely detached.The physician decided to remove the coil and a snare was used to remove the coil, however once the snare was placed the coil partially protruded from the target location; thus, the physician implanted another stent to press the remaining coil against artery wall, only half of the coil could be removed.No further information available.
Additional Manufacturer Narrative
D4: expiration date, added.D4: gtin, updated.H4: manufacturing date, added.Due to the automated manufacturing execution system (mes) 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 directions 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 events could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that during the cerebral aneurysm embolization procedure, when the coil was halfway assembled, it detached from its pusher.An unsuccessful attempt was made to remove the coil which resulted in the coil protruding into the parent vessel.A stent was placed to press the coil against the vessel wall.The procedure was completed without complications and the patient was described as in good general condition additional information indicates the device was in good condition prior to use and there is no indication of a use error.The anatomy was described as moderately 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.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 23729174
• Report Number: 3008881809-2025-00690
• Device Sequence Number: 15888642
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: (01)04546540676559(17)300523(10)25637295
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035476300
• Device Lot Number: 25637295
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL 10 MICROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).; STENT RETRIEVER (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG