MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during ruptured aneurysm procedure, the subject coil detached prematurely inside the microcatheter.The subject device was removed.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil delivery wire was seen to be kinked.The main coil was seen to be detached.The catheter was soaked and eventually cut to remove the coil.(damage caused during analysis) the reminder of the coil was jammed within the shaft.The functional inspection was not applicable.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that during coiling of a ruptured aneurysm, the coil detached while tracking up the microcatheter.The coil was removed together with the microcatheter, and the case was ended without completing the coiling.The device was returned for analysis, and it was noted that the coil had separated from the delivery wire due to a physical break at the detachment zone.The coil was jammed inside the catheter due to the presence of dried procedural fluid.Per the additional information, continuous flush was maintained during the procedure.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the as reported/ as analyzed, 'main coil prematurely detached/separated during use' and to the as analyzed, 'coil jammed'.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of handling damage will be assigned to the as analyzed, 'coil delivery wire kinked/bent'.This defect appears to be associated with handling of the product or portion of the product during the procedure / upon removal of the product from the packaging / preparation of the product prior to use.
Event or Problem Description
It was reported that during ruptured aneurysm procedure, the subject coil detached prematurely inside the microcatheter.The subject device was removed.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 12MM X 45CM
• 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: 23353508
• Report Number: 3008881809-2025-00572
• Device Sequence Number: 9131621
• Product Code: HCG
• UDI-Device Identifier: 07613327128307
• UDI-Public: (01)07613327128307(17)291014(10)25222476
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/05/2026

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: M0036181240
• Device Lot Number: 25222476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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: COILS (UNKNOWN).; EXCELSIOR 1018 (STRYKER).
• Patient Sex: Unknown