MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 6MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180640
Medical Device Problem Codes	Fracture (1260); Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a coil embolization procedure, when the subject coil was being implanted in the aneurysm.It was stretched at the distal end and was unable to be retracted out.The subject coil was migrating to the parent vessel.It was decided to remove the subject coil, while attempting to retrieve it from the vessel, it got prematurely detached.The physician then tried to use a snare device to remove the detached coil, but it got fractured during the process.As a result, it was decided to leave it inside the patient's anatomy.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) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that during the procedure, the subject coil was migrating to the parent vessel.While retrieving the subject coil, it got prematurely detached inside the patient vessel.A snare device was used to remove the detached part but it got fractured and was left inside the patient¿s anatomy.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu (except continuous flush was not set up and maintained throughout the clinical procedure), the tortuosity of the patient's anatomy was average, the coil was not advanced or retracted with force, the microcatheter used in the procedure performed as intended, and the issue occurred in the splenic artery.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during a coil embolization procedure, when the subject coil was being implanted in the aneurysm.It was stretched at the distal end and was unable to be retracted out.The subject coil was migrating to the parent vessel.It was decided to remove the subject coil, while attempting to retrieve it from the vessel, it got prematurely detached.The physician then tried to use a snare device to remove the detached coil, but it got fractured during the process.As a result, it was decided to leave it inside the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 6MM 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: 18343944
• Report Number: 3008881809-2023-00589
• Device Sequence Number: 6202639
• Product Code: HCG
• UDI-Device Identifier: 07613327466409
• UDI-Public: 07613327466409
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 03/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2025
• Device Catalogue Number: M0036180640
• Device Lot Number: 23776282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown