MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180840
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject coil suddenly became very stiff in the midway and couldn¿t be pushed at all.The physician attempted to grasp the subject coil delivery wire with a gauze and advance it further, but it was too stiff to push forward.After repeated pushing and pulling for a while, the physician attempted to leave the subject coil in place, but an early detachment occurred.The subject coil remained inside the microcatheter.The physician then flushed the microcatheter with a syringe and left the subject coil in place.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
C2/d10 concomitant products grid: updated.D4 expiration date: updated.D4 gtin: updated.H4 manufacturing date: updated.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 the subject coil was stiff and it couldn't be advanced from the microcatheter.After repeated pushing and pulling it detached prematurely.The subject coil was flushed from the microcatheter into the aneurysm.Information on the microcatheter used could not be obtained to assess compatibility.The device was not returned for analysis.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 suddenly became very stiff in the midway and couldn¿t be pushed at all.The physician attempted to grasp the subject coil delivery wire with a gauze and advance it further, but it was too stiff to push forward.After repeated pushing and pulling for a while, the physician attempted to leave the subject coil in place, but an early detachment occurred.The subject coil remained inside the microcatheter.The physician then flushed the microcatheter with a syringe and left the subject coil in place.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 8MM X 40CM
• 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: 24341621
• Report Number: 3008881809-2026-00081
• Device Sequence Number: 9423362
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: (01)07613327466423(17)300914(10)25845213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M0036180840
• Device Lot Number: 25845213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/15/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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: LEONISMOVA HF MICROCATHETER (UNKNOWN); MICROCATHETER (UNKNOWN); TARGET TETRA COILS (STRYKER)
• Patient Sex: Unknown