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

Catalog Number	M0036180840
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the subject coil embolization procedure of left sma (superior mesenteric artery), the resistance was encountered while advancing the subject coil within the microcatheter shaft.The subject coil was once retracted and when it was soaked in the saline solution, thrombus was found on the distal tip of the subject coil.The lumen of the microcatheter was flushed, and the subject coil was reinserted; however, resistance was encountered in the shaft again.Therefore, the subject coil was retrieved and replaced with another coil, and the procedure was completed successfully using the same microcatheter.
Additional Manufacturer Narrative
Due to automated manufacturing execution system (mes) has 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 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 when retracted the subject coil, the thrombus formation was observed on the distal tip of the subject coil.Additional information provided by the customer indicated that the device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The subject device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.The patient's anatomy was severely tortuous.An assignable cause of undeterminable will be assigned to as reported 'coil in catheter friction' as 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.A probable cause of anticipated procedural complication will be assigned to as reported 'patient vessel thrombosis' as this appears to be an event where a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that during the subject coil embolization procedure of left sma (superior mesenteric artery), the resistance was encountered while advancing the subject coil within the microcatheter shaft.The subject coil was once retracted and when it was soaked in the saline solution, thrombus was found on the distal tip of the subject coil.The lumen of the microcatheter was flushed, and the subject coil was reinserted; however, resistance was encountered in the shaft again.Therefore, the subject coil was retrieved and replaced with another coil, and the procedure was completed successfully using the same microcatheter.

• 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: 24240672
• Report Number: 3008881809-2026-00058
• Device Sequence Number: 10175176
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: (01)07613327466423(17)300624(10)25666703
• 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): 03/18/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0036180840
• Device Lot Number: 25666703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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: MICROCATHETER (UNKNOWN MANUFACTURER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown