MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Obstruction/Occlusion (2422); Speech Disorder (4415)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 4 months after successful subject coil implantation procedure for a cerebral aneurysm, patent suffered acute right leg weakness, difficulty speaking, obstruction and found to have a stroke.Stroke was caused by the subject coil that had migrated out of the aneurysm and travelled distally into anterior cerebral artery.Patient underwent catheter angiogram, multiple imaging studies and an increase anti-thrombotic medication.She has had a stroke, is disabled from leg weakness resulting from coil migration.
Event or Problem Description
It was reported that 4 months after successful subject coil implantation procedure for a cerebral aneurysm, patent suffered acute right leg weakness, difficulty speaking, obstruction and found to have a stroke.Stroke was caused by the subject coil that had migrated out of the aneurysm and travelled distally into anterior cerebral artery.Patient underwent catheter angiogram, multiple imaging studies and an increase anti-thrombotic medication.She has had a stroke, is disabled from leg weakness resulting from coil migration.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.D4 lot number - updated.D4 gtin - updated.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.It was reported that 4 months after the procedure, the subject coil migrated from the aneurysm.The patient experienced stroke, right leg weakness, difficulty speaking, and obstruction/occlusion.The patient underwent catheter angiogram, multiple imaging studies, and was administered additional anti-thrombotic medication.Additional information provided by the customer indicated that the original procedure was completed successfully with no complications noted during the procedure and that the stroke was caused by the migrated coil.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, a cause of undeterminable will be assigned to the reported event 'main coil migration'.The reported events: 'patient stroke' and 'patient vessel occlusion' are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication will be assigned to these events.Based upon medical review, the events observed in the complaint are anticipated in nature as per the device risk assessment.

• Brand Name: TARGET TETRA 2.5MM X 6.0CM
• 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: 21626709
• Report Number: 3008881809-2025-00145
• Device Sequence Number: 18276711
• Product Code: HCG
• UDI-Device Identifier: 07613327578638
• UDI-Public: (01)07613327578638(17)261001(10)24556253
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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 Expiration Date: 10/01/2026
• Device Catalogue Number: TG5412560
• Device Lot Number: 24556253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Race: White