MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the subject coil got stuck in the coil mass.It was not able to be deployed or removed from the patient.There were no clinical consequences reported due to the event.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D4 lot number - updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.D4 gtin - 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.During visual inspection the coil delivery wire was found to be severely kinked/bent.The main coil was found to be broken/ fractured near the detachment zone.There was dried procedural fluid/blood found on the main coil.The main coil was found to be severely stretched.The main coil suture was found to be damaged.Functional inspection to test the reported event ¿main coil failed/unable to detach¿ could not be replicated during device analysis due to condition of the returned device; however, the analysis results are consistent with the reported event.The reported event ¿main coil detached/separated during use¿ was not confirmed during device analysis.However, the analysis results are consistent with the reported event as the main coil was broken near the main coil junction.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.It was determined that the coil had separated due to a fracture of the main coil near the junction.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the physician experienced difficulty in deploying the coil and the coil separated during removal from the body.Based on device inspection the coil separated during retraction as the main coil fractured, close to the main coil junction.No further information was available.An assignable cause of procedural factors will be assigned to the reported events: main coil failed/unable to detach, main coil prematurely detached/separated during use and to the as analyzed events: main coil stretched, main coil suture damaged and main coil broken/fractured during use.The 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 event: coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product without direct patient contact during shipping/transportation.
Event or Problem Description
It was reported during the procedure the subject coil got stuck in the coil mass.It was not able to be deployed or removed from the patient.There were no clinical consequences reported due to the event.No further information is available.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 21625914
• Report Number: 3008881809-2025-00144
• Device Sequence Number: 17826136
• Product Code: KRD
• UDI-Device Identifier: 07613327128291
• UDI-Public: (01)07613327128291(17)290914(10)25173535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: M0036125150
• Device Lot Number: 25173535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Patient Sex: Unknown