MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 9MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036129300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject coil was successfully implanted into the target aneurysm on (b)(6) 2024.Post-procedure, imaging dsa (digital subtraction angiography) revealed an occlusion status post-implant assessment ¿ raymond class of 1.During patient follow up visits at 3 months, mri (magnetic resonance imaging) test was performed on (b)(6) 2025, as showed occlusion status raymond roy score of 3a.12 months imaging dsa performed on (b)(6) 2025, occlusion status post-implant assessment ¿ raymond class of 3b and mrs (modified rankin scale) was 0.Per physician¿s opinion, the reported event was due to coil compaction as a new embolization procedure will be scheduled to treat an increase in occlusion post implant.No other information was provided.
Event or Problem Description
It was reported that the subject coil was successfully implanted into the target aneurysm on (b)(6) 2024.Post-procedure, imaging dsa (digital subtraction angiography) revealed an occlusion status post-implant assessment ¿ raymond class of 1.During patient follow up visits at 3 months, mri (magnetic resonance imaging) test was performed on (b)(6) 2025, as showed occlusion status raymond roy score of 3a.12 months imaging dsa performed on (b)(6) 2025, occlusion status post-implant assessment ¿ raymond class of 3b and mrs (modified rankin scale) was 0.Per physician¿s opinion, the reported event was due to coil compaction as a new embolization procedure will be scheduled to treat an increase in occlusion post implant.No other information was provided.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned; therefore, physical as well as 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.The event description indicates recanalization was due to coil compaction of both trenza coils and the subject coil.No device malfunction was reported during the initial procedure.A probable cause of anticipated procedural complication will be assigned to this event.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.
Additional Manufacturer Narrative
D4 lot#: updated from 'unknown' to '24935185', d4 gtin: updated, d4: expiration date: added, h4: manufacturing date: added.
Event or Problem Description
It was reported that the subject coil was successfully implanted into the target aneurysm on (b)(6) 2024.Post-procedure, imaging dsa (digital subtraction angiography) revealed an occlusion status post-implant assessment ¿ raymond class of 1.During patient follow up visits at 3 months, mri (magnetic resonance imaging) test was performed on (b)(6) 2025, as showed occlusion status raymond roy score of 3a.12 months imaging dsa performed on (b)(6) 2025, occlusion status post-implant assessment ¿ raymond class of 3b and mrs (modified rankin scale) was 0.Per physician¿s opinion, the reported event was due to coil compaction as a new embolization procedure will be scheduled to treat an increase in occlusion post implant.No other information was provided.

• Brand Name: TARGET XL 360 SOFT 9MM X 30CM
• 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: 22701240
• Report Number: 3008881809-2025-00422
• Device Sequence Number: 18429290
• Product Code: HCG
• UDI-Device Identifier: 04546540711618
• UDI-Public: (01)04546540711618(17)270512(10)24935185
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/24/2026

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: M0036129300
• Device Lot Number: 24935185
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 02/17/2026
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/22/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG