MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421030
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the subject coil was placed into the mca (middle cerebral artery) bifurcation aneurysm as the finishing coil.The coil was detached and three beeps were noted from the power supply.The microcatheter was removed from the aneurysm and the physician found that the subject coil was still briefly attached to the delivery wire which resulted in the subject coil tail protruding from the aneurysm.A stent was placed to pin the protruding subject coil tail against the wall of the vessel.No additional information available.
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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.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 during detachment of the coil as a finishing coil, the power supply signaled that the coil had detached.When removing the microcatheter it was noted that the coil had not fully detached from the delivery wire and the coil was partially pulled into the parent vessel before separating.It is likely that the coil was partially detached electrolytically and then separated physically when pulling back on the delivery wire.However as the device was not returned, this cannot be conclusively determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during the procedure, the subject coil was placed into the mca (middle cerebral artery) bifurcation aneurysm as the finishing coil.The coil was detached and three beeps were noted from the power supply.The microcatheter was removed from the aneurysm and the physician found that the subject coil was still briefly attached to the delivery wire which resulted in the subject coil tail protruding from the aneurysm.A stent was placed to pin the protruding subject coil tail against the wall of the vessel.No additional information available.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 20974746
• Report Number: 3008881809-2024-00614
• Device Sequence Number: 14461282
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: (01)04546540697974(17)270314(10)24839135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113412
• 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): 01/23/2025

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: M0035421030
• Device Lot Number: 24839135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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: MICROCATHETER (UNKNOWN); NEUROFORM ATLAS STENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown