MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coiling procedure, resistance was encountered while advancing the subject coil through the introducer sheath, and the subject coil was not moved as intended while repositioning for framing the aneurysm.To retrieve the subject coil, the hub of the catheters was cut, and a snare device was inserted from a stryker catheter since pulling back the delivery wire was not considered effective.While guiding the snare, the coil was intentionally moved.A coil stretch was confirmed outside the patient during inspection after retrieval.The coil was located in the aneurysm at the time the snare was used.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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 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 the subject coil did not move as intended while repositioning for framing the aneurysm.Additional information provided by the customer indicated that there was a feeling of premature detachment and a snare was used to remove the coil.After removal it was noticed that the coil had stretched but not detached.Friction was noted during advancement of the coil in the sheath which may have contributed to the coil damage.The anatomy was also noted to be severely tortuous which may also have been a factor in the reported events.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 a coiling procedure, resistance was encountered while advancing the subject coil through the introducer sheath, and the subject coil was not moved as intended while repositioning for framing the aneurysm.To retrieve the subject coil, the hub of the catheters was cut, and a snare device was inserted from a stryker catheter since pulling back the delivery wire was not considered effective.While guiding the snare, the coil was intentionally moved.A coil stretch was confirmed outside the patient during inspection after retrieval.The coil was located in the aneurysm at the time the snare was used.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 10MM 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: 23135085
• Report Number: 3008881809-2025-00514
• Device Sequence Number: 9285351
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: (01)07613327004601(17)300321(10)25527019
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0036121040
• Device Lot Number: 25527019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2025
• 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: ATLAS STENT (STRYKER).; DAC CATHETER (STRYKER).; SL- 10 CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown