MAUDE Adverse Event Report: Stryker Neurovascular Cork TARGET 360 NANO 1.5MM X 4CM; Device, Neurovascular Embolization

Catalog Number	M0035421540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, the subject coil encountered resistance while advancing through the microcatheter and got detached prematurely.The procedure was reported to be completed successfully.No clinical consequences were reported to the patient.
Event or Problem Description
It was reported that the coil (subject device) was used in the medical procedure.However, the subject coil encountered resistance while advancing through the microcatheter and got detached prematurely.The procedure was reported to be completed successfully.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).B1 adverse event/product problem - corrected - no product problem.D9 - product available to stryker - updated.D9 - returned to manufacturer on ¿ updated.H1 type of reportable event - corrected - no malfunction.H3 - device evaluated by mfg ¿ updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was not detached but kinked.As a part of functional inspection, the coil was advanced through a demo microcatheter where friction was noted.The reported event of 'coil in catheter friction' was confirmed during analysis.The reported event of 'main coil prematurely detached/separated during use' was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.It was reported that resistance was experienced during advancement of the coil through the microcatheter.Additional information from the customer indicated that the coil prematurely detached, the detached coil was removed, and the procedure was completed using a new device.An assignable cause of 'not confirmed' will be assigned to reported event of 'main coil prematurely detached/separated during use¿ as issue included a returned product review which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.Based on all available information and device analysis, it is probable that unknown anatomical and procedural factors may have contributed to reported and analyzed damaged.Therefore, an assignable cause of 'procedural factors' will be assigned to the reported and analyzed event of ¿coil in catheter friction¿ and analyzed event of ¿main coil kinked/bent¿ as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'handling damage' will be assigned to the analyzed event of 'coil delivery wire kinked/bent' since this issue is most likely due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 NANO 1.5MM 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: 25587935
• Report Number: 3008881809-2026-00382
• Device Sequence Number: 12132843
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: (01)04546540697998(17)300804(10)25767650
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: M0035421540
• Device Lot Number: 25767650
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 114 LB