MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 3MM X 9CM; Device, Neurovascular Embolization

Catalog Number	M0036123090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment of the subject coil was attempted more than 10 times using the power supply, but was unsuccessful.Because detachment could not be achieved, the subject coil retrieval was attempted, during which an aneurysm rupture occurred.The subject coil stretched during retrieval and was subsequently removed using a snare.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The patient is stable.
Event or Problem Description
It was reported that detachment of the subject coil was attempted more than 10 times using the power supply, but was unsuccessful.Because detachment could not be achieved, the subject coil retrieval was attempted, during which an aneurysm rupture occurred.The subject coil stretched during retrieval and was subsequently removed using a snare.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The patient is stable.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added d4 - gtin - added.Due to the automated mes (manufacturing execution system) 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.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 was assigned for the as reported codes 'coil introducer sheath friction', 'main coil stretched', 'main coil failed/unable to detach.' the as reported 'patient aneurysm rupture' is known and anticipated complications to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• Brand Name: TARGET XL 360 SOFT 3MM X 9CM
• 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: 25323308
• Report Number: 3008881809-2026-00340
• Device Sequence Number: 5368386
• Product Code: HCG
• UDI-Device Identifier: 07613327128284
• UDI-Public: (01)07613327128284(17)280129(10)24146602R
• Combination Product (Y/N): N
• 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): 08/27/2026

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: M0036123090
• Device Lot Number: 24146602R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown