MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443560
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that subject coil was prematurely detached during use in patient's vessel.It was also noted that as per physician subject coil kept going out of the aneurysm, and this was because of the aneurysm's morphology.The operator kept trying to push and pull the coil in & out of the stent, and suddenly it was detached without any detachment device connected.As, the subject coil was stuck at the tip of the microcatheter, they could easily remove the coil from the patient's body.No further information available.
Additional Manufacturer Narrative
D4 gtin - added h4 manufacturing date ¿ added d4 expiration 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 coil was not returned for analysis; therefore, physical as well as a functional testing 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.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 will be assigned.
Event or Problem Description
It was reported that subject coil was prematurely detached during use in patient's vessel.It was also noted that as per physician subject coil kept going out of the aneurysm, and this was because of the aneurysm's morphology.The operator kept trying to push and pull the coil in & out of the stent, and suddenly it was detached without any detachment device connected.As, the subject coil was stuck at the tip of the microcatheter, they could easily remove the coil from the patient's body.No further information available.

• Brand Name: TARGET 360 NANO 3.5MM X 6CM
• 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: 22066300
• Report Number: 3008881809-2025-00293
• Device Sequence Number: 20965047
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: (01)07613252600343(17)270909(10)25133400
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113412
• 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): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0035443560
• Device Lot Number: 25133400
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).
• Patient Sex: Unknown