MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 4CM; Device, Neurovascular Embolization

Catalog Number	M0035443040
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, an attempt was made to detach the subject coil, but the subject coil failed to detach.Forceful traction applied to subject coil delivery wire, resulted in breakage at the distal segment of the delivery wire.The detached distal segment could not be retrieved.Follow-up angiography revealed subject coil protrusion, and a rescue stent was placed to manage this complication.The procedure was then completed.There was a surgical delay of unknown minutes due to the reported event.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 3MM 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: 25669783
• Report Number: 3008881809-2026-00412
• Device Sequence Number: 5638613
• Product Code: HCG
• UDI-Device Identifier: 07613252600336
• UDI-Public: (01)07613252600336(17)300902(10)25816291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: M0035443040
• Device Lot Number: 25816291
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: INFINITY PLUS GUIDING CATHETER(STRYKER); INZONE POWER SUPPLY (STRYKER); MC 45 MICROCATHETER (STRYKER); MC S MICROCATHETER (UNKNOWN); NEUROFORM ATLAS STENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female