MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036125150
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 139 days post implant procedure, patient experienced with focal symptoms.The asprin and brilinta were administered n response to the ¿focal symptoms post implant.No other information was provided.
Additional Manufacturer Narrative
This is 2 of 2 reports.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected ¿ no adverse event b2 outcomes attributed to ae: corrected ¿ no other serious (important medical events) b5 executive summary: updated h1 type of reportable event - corrected - no serious injury f10 & h6 device code grid- corrected to ¿insufficient information¿ f10 & h6 clinical signs code grid ¿ corrected to ¿no clinical signs, symptoms or conditions¿ f10 & h6 health impact code grid - corrected to ¿no health consequences or impact¿.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 subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that 139 days post implant procedure, patient experienced with focal symptoms.The asprin and brilinta were administered n response to the ¿focal symptoms post implant.No other information was provided.Update: additional information was provided on 17-oct-2025 that based on physician's assessment, the focal symptoms post implant were largely related to the patient's noncompliance to their medication regiment.Because there was a concern of the integrity of the implant, an magnetic resonance angiography (mra) was ordered at the request of the treating physician to assess safety and integrity of the subject implanted coils and stent due to the patients¿ medication noncompliance.After meeting with the patient, the treating physician does not believe the patients symptoms were due to the implant or procedure.There was not treatment in response to the reported focal symptoms post implant.The patient did not suffer any adverse consequences as a result of ¿focal symptoms post implant'.In physician¿s opinion the subject device performed as intended and there was no allegation against the device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 23230058
• Report Number: 3008881809-2025-00544
• Device Sequence Number: 15910243
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: (01)07613327128291(17)271118(10)25290876
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/23/2025

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: M0036125150
• Device Lot Number: 25290876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 82 KG