MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post procedure, aneurysm recanalization was observed as the retreatment was performed with coilings.Based on the site, the adverse event aneurysm reoccurrence was possibly related to the subject device.The outcome of this adverse event is ongoing.No further information is available.
Event or Problem Description
It was reported that post procedure, aneurysm recanalization was observed as the retreatment was performed with coilings.Based on the site, the adverse event aneurysm reoccurrence was possibly related to the subject device.The outcome of this adverse event is ongoing.No further information is available.
Additional Manufacturer Narrative
D1 product long description: corrected.D4 catalog #: corrected.D4 lot#: updated.D4 expiration date/ gtin: updated.H4 manufacturing date: updated.Due to the automated manufacturing execution system (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 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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The event description indicates a possible relationship to the target coils.No device malfunction was reported during the initial procedure.A probable cause of anticipated procedural complication will be assigned to this event.This appears to be an event where a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the directions for use, product labeling and/or risk documentation files.

• Brand Name: TARGET 360 SOFT 4MM X 8CM
• 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: 22038949
• Report Number: 3008881809-2025-00286
• Device Sequence Number: 21059970
• Product Code: HCG
• UDI-Device Identifier: 04546540676467
• UDI-Public: (01)04546540676467(17)261219(10)24674371
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/02/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0035474080
• Device Lot Number: 24674371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White