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

Model Number	M0035422030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
Event or Problem Description
It was reported that subject coil was used for the dissociation of the aca (anterior cerebral artery) distal before treating the a-com (anterior communicating artery) aneurysm.After placing subject coil to the targeted lesion aca (anterior cerebral artery) distal and when attempt was made to detach the subject coil, detachment system could not work and subject coil could not be detached.So physician withdrew the coil delivery wire and proceeded for a-com (anterior communicating artery) coil embolization with new device.It was assumed that the subject coil was removed without any problem during the case since the condition was not confirmed.When other coil was placed in the aneurysm and got detached by using detachment system, it could not be filling neatly in the aneurysm.So physician thought that other coil was stretched or prematurely detached.He removed it from the aneurysm and inspected it.Other coil had kept the prototype quite a bit, so it was thought that some foreign substance was mixed in the introducer sheath of the coil and that it was left behind in the aneurysm.By carefully examining the images and videos of this case, it was confirmed that the entire subject coil did not removed and remained in the catheter.Therefore, it was considered that the other coil that inserted afterwards pushed out the subject coil left in the catheter entered the aneurysm, and when the other coil was removed, the subject coil remained in the aneurysm and it could be placed neatly.It has been confirmed by ct inspection that it was unlikely of stretch, and it was said that the subject coil may have been prematurely detached from the detached part.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that subject coil was used for the dissociation of the aca (anterior cerebral artery) distal before treating the a-com (anterior communicating artery) aneurysm.After placing subject coil to the targeted lesion aca (anterior cerebral artery) distal and when attempt was made to detach the subject coil, detachment system could not work and subject coil could not be detached.So physician withdrew the coil delivery wire and proceeded for a-com (anterior communicating artery) coil embolization with new device.It was assumed that the subject coil was removed without any problem during the case since the condition was not confirmed.When other coil was placed in the aneurysm and got detached by using detachment system, it could not be filling neatly in the aneurysm.So physician thought that other coil was stretched or prematurely detached.He removed it from the aneurysm and inspected it.Other coil had kept the prototype quite a bit, so it was thought that some foreign substance was mixed in the introducer sheath of the coil and that it was left behind in the aneurysm.By carefully examining the images and videos of this case, it was confirmed that the entire subject coil did not removed and remained in the catheter.Therefore, it was considered that the other coil that inserted afterwards pushed out the subject coil left in the catheter entered the aneurysm, and when the other coil was removed, the subject coil remained in the aneurysm and it could be placed neatly.It has been confirmed by ct inspection that it was unlikely of stretch, and it was said that the subject coil may have been prematurely detached from the detached part.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be 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 subject coil was used before using the above ied coil, and it was removed without being placed in the aneurysm.(it was assumed that the coil was removed without any problem during the case since the condition was not confirmed.).By carefully examining the images and videos of this case, it was confirmed that the entire target coil did not removed and remained in the catheter.It has been confirmed by ct inspection that it was unlikely of stretch, and it was said that the target coil may have been prematurely detached from the detached part for some reason.Additional information provided by the customer indicated that the ied coil detached by using detachment system after placing it in the aneurysm.No adverse effect noted to the patient due the reported issue.It is not known how many attempts were made to detach the subject target coil with inzone.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint which was reported for main coil prematurely detached/separated during use, device interaction with another device and main coil failed/unable to detach.

• Brand Name: TARGET 360 ULTRA 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
• MDR Report Key: 12104618
• Report Number: 3008881809-2021-00287
• Device Sequence Number: 3577629
• Product Code: HCG
• UDI-Device Identifier: 04546540675835
• UDI-Public: 04546540675835
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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 Expiration Date: 09/30/2023
• Device Model Number: M0035422030
• Device Catalogue Number: M0035422030
• Device Lot Number: 22477442
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1