MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.5MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412545
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the anterior communicating artery procedure, the physician tried to detach the subject coil.Although the power supply beeped 3 times, the subject coil did not detach.The subject main coil stretched and was dislodged from the coil mass as the physician tried to pull out the subject coil delivery wire.The subject main coil migrated to a2 segment.The physician then deployed a stent retriever and pulled the subject main coil into the catheter.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 20-30 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.
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.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device direction 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 while pulling the delivery wire, the subject coil appeared to stretch and prematurely detach.The subject coil was dislodged from the coil mass and made its way into the a2 segment.The physician deployed a stent retriever through a catheter and pulled the subject coil into a catheter to remove it.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, no attempts were made to re-position the subject coil within the aneurysm, no resistance was encountered within the microcatheter during advancement, excessive force was not applied at any point in the procedure, and the coil appeared to still be attached to the delivery wire when the physician pulled back on the wire after the power supply beeped 3 times.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 anterior communicating artery procedure, the physician tried to detach the subject coil.Although the power supply beeped 3 times, the subject coil did not detach.The subject main coil stretched and was dislodged from the coil mass as the physician tried to pull out the subject coil delivery wire.The subject main coil migrated to a2 segment.The physician then deployed a stent retriever and pulled the subject main coil into the catheter.The subject device was replaced, and the procedure was completed successfully.There was a surgical delay of 20-30 minutes due to the reported event.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 2.5MM X 4.5CM
• 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: 23649068
• Report Number: 3008881809-2025-00670
• Device Sequence Number: 9896664
• Product Code: HCG
• UDI-Device Identifier: 07613327578621
• UDI-Public: (01)07613327578621(17)300616(10)25672269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TG5412545
• Device Lot Number: 25672269
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: GUIDEWIRE (UNKNOWN); RED 72 CATHETER (PENUMBRA); SOLITAIRE STENT RETRIEVER (MEDTRONIC); VELOCITY CATHETER (PENUMBRA)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown