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

Catalog Number	M0036121040
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during aneurysm embolization case, the operator reported resistance while advancing the subject coil through the microcatheter.The coil was eventually deployed entirely within the aneurysm sac.After approximately five minutes, the operator decided to reposition the coil.During retrieval, the pusher wire became floppy and subsequently fractured.The coil was then re-advanced into the sac; however, approximately 5 mm of the coil remained outside.Detachment could not be achieved, as the detachment zone of the pusher wire had separated from the remainder of the system.To retrieve the residual coil mass, the operator attempted to trap it using the previously deployed coil-assisted flow diverter.This approach was initially successful until the flow diverter¿s pusher wire detached, leaving the device within the common carotid artery.After multiple retrieval attempts using various stent retrievers and gooseneck snares, the physician successfully removed the flow diverter and most of the stretched coil.Despite several additional hours of effort, a portion of the coil fragments within the aneurysm sac could not be retrieved.The procedure was subsequently completed using alternative coils.The patient retains a segment of the original subject coil protruding from the aneurysm through the median artery into the internal carotid artery.Surgical delay of 180 minutes was observed, and the physician intends to retreat the patient in the coming days.No adverse clinical events occurred, and the patient achieved full recovery without morbidity.
Event or Problem Description
It was reported that during aneurysm embolization case, the operator reported resistance while advancing the subject coil through the microcatheter.The coil was eventually deployed entirely within the aneurysm sac.After approximately five minutes, the operator decided to reposition the coil.During retrieval, the pusher wire became floppy and subsequently fractured.The coil was then re-advanced into the sac; however, approximately 5 mm of the coil remained outside.Detachment could not be achieved, as the detachment zone of the pusher wire had separated from the remainder of the system.To retrieve the residual coil mass, the operator attempted to trap it using the previously deployed coil-assisted flow diverter.This approach was initially successful until the flow diverter¿s pusher wire detached, leaving the device within the common carotid artery.After multiple retrieval attempts using various stent retrievers and gooseneck snares, the physician successfully removed the flow diverter and most of the stretched coil.Despite several additional hours of effort, a portion of the coil fragments within the aneurysm sac could not be retrieved.The procedure was subsequently completed using alternative coils.The patient retains a segment of the original subject coil protruding from the aneurysm through the median artery into the internal carotid artery.Surgical delay of 180 minutes was observed, and the physician intends to retreat the patient in the coming days.No adverse clinical events occurred, and the patient achieved full recovery without morbidity.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that subject device was returned tangled together.The subject coil delivery wire was seen to be severely kinked/bent.The main coil was seen to be stretched and broken/fractured.The proximal end of the delivery wire was seen to be broken/fractured and missing.The main coil suture was missing.The main coil introducer sheath was not returned.Functional inspection was unable to perform due to the damage noted to the device.The reported event is covered in the device direction 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 was confirmed based on device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Information provided in the complaint indicates that excessive force was applied to advance the subject coil due to friction.The use of a torquer is likely to have contributed to the excessive force and potential twisting of the delivery wire which resulted in the fracture.The device was returned for analysis, and it was noted that subject delivery wire was badly damaged.The subject coil was broken close to the main coil junction.The coil was also severely stretched, and no suture was present in the return.It is likely that the suture remains in the patient along with the distal portion of the coil.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• 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: 23605033
• Report Number: 3008881809-2025-00650
• Device Sequence Number: 9841240
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: (01)07613327004601(17)270526(10)24979439
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; NEQSTENT (CERUS).; SNARE (UNKNOWN).; STENT RETRIEVERS (UNKNOWN).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female