MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 10CM; Device, Neurovascular Embolization

Catalog Number	TG5413010
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure last few centimeters of the subject coil was difficult to place in aneurysm and was manipulated quite a lot.The subject coil detached prematurely while it was manipulated trying to get into the aneurysm.The coil was retrieved with a retriever stent.There was 1 hour of surgical delay due to the event.No other clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.0MM 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 ; +1(510)413-2500
• MDR Report Key: 25816772
• Report Number: 3008881809-2026-00450
• Device Sequence Number: 16135829
• Product Code: HCG
• UDI-Device Identifier: 07613327578676
• UDI-Public: (01)07613327578676(17)261128(10)24650726
• 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): 10/01/2026

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: TG5413010
• Device Lot Number: 24650726
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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: SL10 MICROCATHETER (STRYKER).; TREVO RETRIEVER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown