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

Catalog Number	TG5411530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during coil embolization procedure, an increase in eosinophils and local swelling were detected.An allergic reaction was suspected.No further information available.
Event or Problem Description
It was reported that during coil embolization procedure, an increase in eosinophils and local swelling were detected.An allergic reaction was suspected.No further information available.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has 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 an examination after coil embolization showed an increase in eosinophils and local swelling, and a metal allergy was suspected possibly due to the implanted coil mass.Additional information provided by the customer indicated the following: a metal patch test was performed and there was a reaction with nickel.Estimated to have a reaction even with very small amounts and a fairly low threshold.Symptoms were treated with antihistamines for 3 days after coil embolization, and then no further dosing.In addition to metal allergy, eosinophils tended to increase during embolization with nbca (liquid embolization material) rather than coils, suggesting that the patient was prone to allergic reactions in addition to metal allergy.The reported events: 'patient complications' and 'patient allergic reaction' 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.

• 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: 21870021
• Report Number: 3008881809-2025-00218
• Device Sequence Number: 19889079
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: 07613327580105
• 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): 07/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TG5411530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 04/19/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: COIL (NON-STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female