MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412045
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During balloon assisted coil embolization for an unruptured aneurysm, the subject coil was placed and detached as planned.However, after detachment and balloon deflation, the entire coil migrated into the middle cerebral artery.A goose neck snare device was used to retrieve the migrated coil, but arterial bleeding was observed.Temporary occlusion with the guiding balloon was applied to achieve hemostasis.Once bleeding was controlled, the procedure was completed successfully.Additional information indicates that the patient is stable.
Event or Problem Description
During balloon assisted coil embolization for an unruptured aneurysm, the subject coil was placed and detached as planned.However, after detachment and balloon deflation, the entire coil migrated into the middle cerebral artery.A goose neck snare device was used to retrieve the migrated coil, but arterial bleeding was observed.Temporary occlusion with the guiding balloon was applied to achieve hemostasis.Once bleeding was controlled, the procedure was completed successfully.Additional information indicates that the patient is stable.
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.The visual and functional inspection was not applicable as the product was not returned for analysis.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.It was reported that after detaching the coil and deflating the balloon, the entire coil migrated into the artery.The coil could be removed by goose neck snare device, but bleeding was confirmed from the artery.Temporary occlusion with the guiding balloon was maintained to achieve hemostasis.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.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 as reported code main coil migration.The reported 'patient hemorrhage, blood loss with sequelae' is a known and anticipated complication 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 TETRA 2.0MM X 4.5CM
• 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: 24384439
• Report Number: 3008881809-2026-00097
• Device Sequence Number: 16074816
• Product Code: HCG
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/15/2026

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: TG5412045
• Device Lot Number: 25849197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2025
• 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: BALLOON (UNKNOWN).; BALLOON (UNKNOWN).; GOOSE NECK SNARE (UNKNOWN).; GOOSE NECK SNARE (UNKNOWN).; TARGET COILS (STRYKER).; TARGET COILS (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female