MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a 3-month follow up, the imaging revealed a fishmouthing of the flow diverter stent at the distal end.The subject coil was also used to treat the internal carotid artery (ica) aneurysm.The patient previously experienced weakness in one lower limb, but the condition has improved and is now stable.No other information is available.
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.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.Based upon medical review assessment, the harm observed in the complaint is anticipated in nature as per the device risk assessment.During a 3-month follow up, the customer reported that the patient previously experienced weakness in one lower limb, but the condition has improved and is now stable.The complaint also indicates that there was fishmouthing associated with an implanted flow diverter stent.There is no indication of any coil device malfunction during the initial procedure or on 3-month follow up.The relationship of the adverse event to the subject coil is unclear and no further information was provided.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.
Event or Problem Description
It was reported that during a 3-month follow up, the imaging revealed a fishmouthing of the flow diverter stent at the distal end.The subject coil was also used to treat the internal carotid artery (ica) aneurysm.The patient previously experienced weakness in one lower limb, but the condition has improved and is now stable.No other information is available.

• Brand Name: TARGET 360 ULTRA 4MM X 10CM
• 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: 21484615
• Report Number: 3008881809-2025-00105
• Device Sequence Number: 8546650
• Product Code: HCG
• UDI-Device Identifier: 07613252192336
• UDI-Public: (01)07613252192336(17)270407(10)24882911
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/04/2025

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: M0035424100
• Device Lot Number: 24882911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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: SURPASS EVOLVE STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown