MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 4.0MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5414080
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The visual inspection was not performed due to the device not returned.The functional inspection was not performed due to the device not returned.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 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.It was reported that once the subject coil was detached, the coil was stretched upon removing the delivery wire.The power supply detachment device gave a good detachment signal, and the coil marker was visibly past the proximal marker of the microcatheter when detached.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the directions for use (dfu), continuous flush was maintained throughout the procedure, the anatomy was not tortuous, the subject coil was retracted with a usual amount of force, and a small portion of the coil protruded into the vessel but was tacked back into the aneurysm with subsequent coils.While there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.
Event or Problem Description
It was reported that during the procedure, once the subject coil was detached, the coil was stretched upon removing the delivery wire.Additional information received on 02-oct-2025 stated that a small portion of the subject coil protruded into the vessel and additional coils were deployed as medical intervention.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, once the subject coil was detached, the coil was stretched upon removing the delivery wire.Additional information received on 02-oct-2025 stated that a small portion of the subject coil protruded into the vessel and additional coils were deployed as medical intervention.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET TETRA 4.0MM X 8.0CM
• 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: 23398762
• Report Number: 3008881809-2025-00586
• Device Sequence Number: 10015380
• Product Code: HCG
• UDI-Device Identifier: 07613327578720
• UDI-Public: (01)07613327578720(17)260725(10)24439390
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2026
• Device Catalogue Number: TG5414080
• Device Lot Number: 24439390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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: SL-10 MICROCATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown