MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035442030
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available for evaluation.
Event or Problem Description
It was reported during the procedure the subject coil would not detach after deployment in the aneurysm.When the physician was removing the subject coil, it got stuck and then detached and traveled to the patients middle cerebral artery (mca) distal branch.The physician attempted to retrieve the detached coil by performing aspiration, but the subject coil continued to travel further in the patients mca and was unable to be removed.The subject coil migrated far enough that it did not impact the patient or the procedure.The procedure was completed successfully.The patients condition is stable.
Event or Problem Description
It was reported during the procedure the subject coil would not detach after deployment in the aneurysm.When the physician was removing the subject coil, it got stuck and then detached and traveled to the patients middle cerebral artery (mca) distal branch.The physician attempted to retrieve the detached coil by performing aspiration, but the subject coil continued to travel further in the patients mca and was unable to be removed.The subject coil migrated far enough that it did not impact the patient or the procedure.The procedure was completed successfully.The patients condition is stable.
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 delivery wire was seen to be kinked/bent.The main coil was seen to be detached/separated from the delivery wire.Functional inspection was not performed.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 main coil prematurely detached/separated during use was confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The information received reports that the main coil did not detach but when the delivery wire was retracted that the main coil got stuck in the microcatheter and migrated up the middle cerebral artery (mca).Based on the analysis of the returned delivery wire it is likely that partial detachment occurred electrolytically, and the final separation was physical while the delivery wire was being retracted.The main coil detachment zone could not be inspected as the coil was implanted.An assignable cause of procedural factors will be assigned to the reported and analyzed event of the main coil prematurely detached/separated during use and the as reported damage of main coil failed/unable to detach, coil difficult to remove/withdraw from catheter, main coil migration, and un-retrieved device fragments as this complaint is 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analyzed damage of the coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET 360 NANO 2MM X 3CM
• 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: 19102778
• Report Number: 3008881809-2024-00163
• Device Sequence Number: 7343657
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 06/18/2024

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: 05/13/2026
• Device Catalogue Number: M0035442030
• Device Lot Number: 24332764
• 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: 03/31/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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: ASPIRATION CATHETER (UNKNOWN); EXCELSIOR SL-10 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown