MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432560
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during incidental cerebral aneurysm procedure, the operator tried to extract the subject coil once the release process had started.The subject coil could not be removed from the patient's anatomy, which caused patient's death.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.D4 gtin - updated.F10 / h6 medical device problem code - 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.Visual and functional inspections were not conducted due to the device was not returned.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 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.It was reported that while the physician was detaching the coil, they pulled back on the delivery wire before the coil had detached.This resulted in movement of the coil which caused the patient death.Per the dfu, "once coil detachment has been fluoroscopically confirmed, slowly withdraw the delivery wire from the microcatheter".The issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.There was a deviation from the supplied ifu.Therefore an assignable cause of use error will be assigned to the reported events: 'patient death', 'main coil prematurely detached/separated during use', 'unretrieved device fragments'.
Event or Problem Description
It was reported that during incidental cerebral aneurysm procedure, the operator tried to extract the subject coil once the release process had started.The subject coil could not be removed from the patient's anatomy, which caused patient's death.

• Brand Name: TARGET HELICAL ULTRA 2.5MM 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: 22375075
• Report Number: 3008881809-2025-00369
• Device Sequence Number: 7953085
• Product Code: HCG
• UDI-Device Identifier: 04546540676054
• UDI-Public: (01)04546540676054(17)260708(10)24416276
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 09/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Catalogue Number: M0035432560
• Device Lot Number: 24416276
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEUROFORM ATLAS STENT (STRYKER).; XT-17 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Death
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 90 KG