MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Paresis (1998); Foreign Body In Patient (2687); Speech Disorder (4415)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cerebral aneurysm embolization, endovascular interventional procedure, there was stretching of the subject coil, resulting in detachment from the pusher and inability to recapture it.The primary nylon filament came out of the coil.The coil and nylon remained in the patient's left carotid artery, aorta, and right iliac-femoral axis.The patient experienced right upper limb paresis and mild dysarthria.The patient awoke with mild palsy of the seventh cerebral artery, mild dysarthria, and plegia in the right upper limb.Over the next 6 days, there was a marked improvement in her clinical condition: complete resolution of the dysarthria and seventh cerebral artery palsy, partial resolution of the plegia in the right upper limb, and a complete motor deficit in the hand.
Additional Manufacturer Narrative
Section a2 age at time of event and age units (patient) ¿ added.B2 outcomes attributed to ae - updated.B5 executive summary - updated.F10 / h6 health impact code grid - health effect - impact code - updated.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 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 upon medical review, the event observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.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 the target coil stretched and separated prematurely from the delivery wire.The coil was unable to be retrieved and remained in the patient's left carotid artery, aorta, and right iliac-femoral axis.The aneurysm was embolized with simple coiling to secure it.Since it was not possible to completely remove the primary coil filament in the left middle cerebral artery and left internal carotid artery, dual antiplatelet therapy was initiated.The device was not returned for analysis.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 was assigned to the as reported 'main coil prematurely detached/separated during use', 'main coil stretched', 'un-retrieved device fragments', 'patient neurological deficit.'.
Event or Problem Description
It was reported that during cerebral aneurysm embolization, endovascular interventional procedure, there was stretching of the subject coil, resulting in detachment from the pusher and inability to recapture it.The primary nylon filament came out of the coil.The coil and nylon remained in the patient's left carotid artery, aorta, and right iliac-femoral axis.The patient experienced right upper limb paresis and mild dysarthria.The patient awoke with mild palsy of the seventh cerebral artery, mild dysarthria, and plegia in the right upper limb.Over the next 6 days, there was a marked improvement in her clinical condition: complete resolution of the dysarthria and seventh cerebral artery palsy, partial resolution of the plegia in the right upper limb, and a complete motor deficit in the hand.Additional information received stated that an attempt was made to remove the coil together with the neqstent device, trying to use the neqstent as a loop; the attempt was partially unsuccessful, so multiple removal attempts were then performed using a stent retriever and gooseneck, with partial success (the neqstent and part of the filament in the vessel were removed).The patient experienced right upper limb plegia, mild dysarthria, and mild deficit of the right vii cranial nerve.At discharge, the patient had recovered everything except the plegia of the right hand (she could move the shoulder, elbow, and wrist).The patient reported being able to move the hand, with some difficulty in fine movements, showing clear improvement (mrs = 1).No additional information is available.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 23623640
• Report Number: 3008881809-2025-00661
• Device Sequence Number: 10045036
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: (01)07613327004601(17)270526(10)24979439
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: IT
• 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): 01/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0036121040
• Device Lot Number: 24979439
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Unknown