MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413045
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure; the subject coil became stuck inside the catheter and would not advance forward or backward nor detach with inzone.Eventually the coil came off of the delivery wire and left loop in parent vessel.The physician had to place a neuroform atlas stent to tack down loop.There was a surgical delay of 30 minutes.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the subject coil became stuck inside the catheter and would not advance forward or backward nor detach with inzone.Eventually the coil came off of the delivery wire and left loop in parent vessel.The physician had to place a neuroform atlas stent to tack down loop.There was a surgical delay of 30 minutes.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection was not performed due to the product not being returned.Functional inspection was not performed due to the product not being 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 the subject coil became stuck and would not advance forward or backward or detach with the inzone.Eventually it came off the wire and left a loop in the parent vessel.A neuroform atlas stent had to be placed to tack down the loop.On follow up ct imaging, there appeared to be more coil in the parent vessel not seen on angio.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use, the issue occurred when deploying the 5th coil, a phenom 17 90 deg microcatheter was used with the subject coil, the subject coil was not advanced or retracted with force, there were no issues with the microcatheter and no issues with the first 4 coils, and there were no detachment issues using the inzone with the first 4 coils or 3 coils after.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.

• Brand Name: TARGET TETRA 3.0MM 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: 23075262
• Report Number: 3008881809-2025-00499
• Device Sequence Number: 15882859
• Product Code: HCG
• UDI-Device Identifier: 07613327578645
• UDI-Public: (01)07613327578645(17)270324(10)24869228
• 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): 10/17/2025

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: TG5413045
• Device Lot Number: 24869228
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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: NEUROFORM ATLAS STENT (STRYKER).; PHENOM 17 90 DEG (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown