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

Catalog Number	M0036124080
Medical Device Problem Codes	Positioning Failure (1158); Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.
Event or Problem Description
It was reported that during procedure, the subject device was herniated, however, according to procedure notes and the subject device was never deployed due to difficulties in accessing the target location.No other information was provided.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no product problem b5 executive summary: updated d4 expiration date ¿ added d4 gtin- added h4 manufacturing date ¿ added h1 type of reportable event - corrected - no malfunction f10 & h6 device code grid- corrected to 'position failure' 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.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.Based on the information provided, the site reported the subject coil device event as coil herniation; however, according to procedure notes, the microcatheter was herniated and the 4th target coil was never deployed due to difficulties in accessing the target location and it was withdrawn from the patient.Additional information from the complaint indicated that the subject device was confirmed to be in good condition prior to use and preparation/set-up was performed as per the directions for use.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during procedure, the subject device was herniated, however, according to procedure notes and the subject device was never deployed due to difficulties in accessing the target location.No other information was provided.Update: received additional information on (b)(6) 2026 confirmed that the subject coil was never deployed due to difficulties in accessing the target location and it was withdrawn from the patient.Based on the information, this event does not meet reporting criteria anymore.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 XL 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: 23838583
• Report Number: 3008881809-2025-00735
• Device Sequence Number: 15854899
• Product Code: HCG
• UDI-Device Identifier: 07613327128390
• UDI-Public: (01)07613327128390(17)300218(10)25468540
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/23/2026

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: M0036124080
• Device Lot Number: 25468540
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER).
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White