MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035424060
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the coil (subject device) was accidentally deployed partially outside of an acom ( anterior communicating artery) aneurysm and was suspended in the parent aca (anterior cerebral artery) vessel.The physician successfully retrieved the coil using a retriever and catheter (under aspiration).The patient developed vasospasm in the right mca (middle cerebral artery) which cleared after 10 minutes of the physician administering verapamil.The physician successfully completed the procedure by placing five coils in the aneurysm and the patient was stable post procedure.
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 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.Additional information provided by the customer indicated that continuous flush was maintained for the duration of the procedure and the device was prepared as per the dfu.A target coil was accidentally deployed partially outside of the aneurysm and was suspended in the parent anterior cerebral artery vessel.The physician initially put the inzone over the proximal end of the 4x6 coil, but then immediately removed the inzone before completing a cycle.He had decided at the last second that he wanted to keep that coil attached.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 was assigned to this complaint.
Event or Problem Description
It was reported that during the procedure the coil (subject device) was accidentally deployed partially outside of an acom ( anterior communicating artery) aneurysm and was suspended in the parent aca (anterior cerebral artery) vessel.The physician successfully retrieved the coil using a retriever and catheter (under aspiration).The patient developed vasospasm in the right mca (middle cerebral artery) which cleared after 10 minutes of the physician administering verapamil.The physician successfully completed the procedure by placing five coils in the aneurysm and the patient was stable post procedure.

• Brand Name: TARGET 360 ULTRA 4MM X 6CM
• 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: 15500202
• Report Number: 3008881809-2022-00469
• Device Sequence Number: 11234119
• Product Code: HCG
• UDI-Device Identifier: 04546540675910
• UDI-Public: 04546540675910
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/30/2022

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: 03/09/2024
• Device Model Number: M0035424060
• Device Catalogue Number: M0035424060
• Device Lot Number: 22788826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: AXS VECTA ASPIRATION CATHETER (STRYKER); SOLITAIRE RETRIEVER (MEDTRONIC); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female