MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 3.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during 6 months follow up after subject coil implantation procedure for anterior cerebral artery aneurysm, the subject coil had travelled distally into anterior cerebral artery.Patient currently seems asymptomatic from this event.She has had leg weakness; however, this symptom is not clearly attributable to this subject coil migration event.The patient underwent additional testing but does not appear to have been injured.Patient is continued on anti-thrombotic medications.
Additional Manufacturer Narrative
D4 expiration date - added d4 lot # - corrected d4 gtin - added h4 manufacturing date ¿ added due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot 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.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 at 6 month follow up after the subject coil implantation procedure, it was observed that the subject coil had migrated distally into the anterior cerebral artery (aca).Additional information provided by the customer indicated that there were no difficulties encountered during preparation/transferring/advancement/withdrawal of the subject device that could have contributed to the reported issue, there were no problems encountered during the initial treatment procedure, the patient underwent additional outpatient testing but does not appear to have been injured, and the patient has continued on anti-thrombotic medications due to the reported event.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 this complaint.Based upon medical review, the event observed in the complaint is anticipated in nature as per the device risk assessment.
Event or Problem Description
It was reported that during 6 months follow up after subject coil implantation procedure for anterior cerebral artery aneurysm, the subject coil had travelled distally into anterior cerebral artery.Patient currently seems asymptomatic from this event.She has had leg weakness; however, this symptom is not clearly attributable to this subject coil migration event.The patient underwent additional testing but does not appear to have been injured.Patient is continued on anti-thrombotic medications.

• Brand Name: TARGET TETRA 1.5MM X 3.0CM
• 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: 21590390
• Report Number: 3008881809-2025-00133
• Device Sequence Number: 15684772
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: (01)07613327580105(17)260101(10)24099544
• Combination Product (Y/N): N
• 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): 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: 01/01/2026
• Device Catalogue Number: TG5411530
• Device Lot Number: 24099544
• 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: 03/12/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COILS (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White