MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036128300
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during ruptured aneurysm procedure; the operator used the subject coil as the first coil.However, after about 1/4 of the coil went out of the microcatheter, the coil detached prematurely.The detached coil occluded the internal carotid artery (ica) and middle cerebral artery (mca).The operator tried to use multiple tools such as 6 stent retrievers, 2 snares and a filter wire to extract the subject coil but unsuccessfully as only fragments of the subject coil were coming out.The operator decided to stent the remaining part of the vessel to cover the loose floating coil.This resulted in 8 hours surgical delay.The patient experienced significant vascular occlusion, deficit and died.
Additional Manufacturer Narrative
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.The coil was used with a compatible microcatheter and was not advanced or retracted with force.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 reported events: ¿main coil prematurely detached/separated during use¿, ¿patient neurological deficit¿, ¿patient vessel occlusion¿, ¿patient death¿, ¿un-retrieved device fragments¿, ¿main coil broken/fractured during use¿.
Event or Problem Description
It was reported that during ruptured aneurysm procedure, the operator used the subject coil as the first coil.However, after about 1/4 of the coil went out of the microcatheter, the coil detached prematurely.The detached coil occluded the internal carotid artery (ica) and middle cerebral artery (mca).The operator tried to use multiple tools such as 6 stent retrievers, 2 snares and a filter wire to extract the subject coil but unsuccessfully as only fragments of the subject coil were coming out.The operator decided to stent the remaining part of the vessel to cover the loose floating coil.This resulted in 8 hours surgical delay.The patient experienced significant vascular occlusion, deficit and died.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• 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: 22984029
• Report Number: 3008881809-2025-00481
• Device Sequence Number: 15840161
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: (01)07613327004649(17)300217(10)25448920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/21/2025

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 Catalogue Number: M0036128300
• Device Lot Number: 25448920
• 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: 08/16/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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: FILTER WIRE (UNKNOWN).; RETRIEVERS (UNKNOWN).; SNARE DEVICES (UNKNOWN).; STENT (UNKNOWN).; TREVO RETRIEVER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Death; Other
• Patient Sex: Unknown