MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413080
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
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 stent assisted coiling was performed with a stent, and the aneurysm was framed with framing coil and filled with subject coil.When the operator tried to detach the subject coil, it failed.The subject coil did not detach even when the operator used a new power supply.When the operator tried to pull out the subject coil and microcatheter, they stretched, and the subject coil suddenly broke out and the coil loop migrated to the parent artery.The operator used a second stent to attach the coil loop to the vessel wall.No additional information was received for this complaint.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 was assigned to this complaint.
Event or Problem Description
It was reported that during right posterior communicating artery (pcoma) aneurysm procedure, the operator performed stent assisted coiling.The subject coil failed to detach even with new power supply.When the subject coil and microcatheter were pulled, they got stretched.The subject coil suddenly broke out and the loop of the subject coil migrated to the parent artery.The operator used stent to attach the subject coil loop to the vessel wall.The operator tried to select the catheter to aneurysm to put the subject coil again, but selection was impossible since the stent was bifold.Therefore, the procedure completed with just attaching the subject coil on the vessel wall.There was a surgical delay of 15 min due to the reported event.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during right posterior communicating artery (pcoma) aneurysm procedure, the operator performed stent assisted coiling.The subject coil failed to detach even with new power supply.When the subject coil and microcatheter were pulled, they got stretched.The subject coil suddenly broke out and the loop of the subject coil migrated to the parent artery.The operator used stent to attach the subject coil loop to the vessel wall.The operator tried to select the catheter to aneurysm to put the subject coil again, but selection was impossible since the stent was bifold.Therefore, the procedure completed with just attaching the subject coil on the vessel wall.There was a surgical delay of 15 min due to the reported event.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.0MM 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: 21580424
• Report Number: 3008881809-2025-00127
• Device Sequence Number: 15642785
• Product Code: HCG
• UDI-Device Identifier: 07613327578669
• UDI-Public: (01)07613327578669(17)270325(10)24870908
• 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): 05/02/2025

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 Catalogue Number: TG5413080
• Device Lot Number: 24870908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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: ATLAS- 4.5*21(STRYKER).; ATLAS- 4.5*30 (STRYKER).; SL-10 (STRYKER).; TARGET TETRA- 4*8 (STRYKER).; TARGET TETRA- 4.5*10 (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown