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

Model Number	M0035442030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Numbness (2415); Thromboembolism (2654); Ischemia Stroke (4418)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported after the study procedure about 9 hours, the patent had an ischemic stroke at the right parietal lobe.Patient was essentially back to baseline by the following day, with the exception of minimal numbness.8 days post procedure, patient presented to the er (emergency room) with the same initial symptoms in addition to transient blurred vision in the left eye.Patient was kept for 12 hours for observation.Had ct (computed tomography) and mri (magnetic resonance imaging) done which both reflected no change.Per neurologist, "suspect symptoms are related to recrudescence of previous punctate infarct earlier this month.The cause of stroke post procedure was thromboembolism.Patient was started on clopidogrel and atorvastatin when released to home.The outcome of this adverse event is ¿ongoing¿ at this moment.In physician¿s opinion, there were no any difficulties encountered during the procedure that could have contributed to the patient's stroke post procedure as the subject coil device was performed as intended.No other information was provided.
Event or Problem Description
It was reported after the study procedure about 9 hours, the patent had an ischemic stroke at the right parietal lobe.Patient was essentially back to baseline by the following day, with the exception of minimal numbness.8 days post procedure, patient presented to the er (emergency room) with the same initial symptoms in addition to transient blurred vision in the left eye.Patient was kept for 12 hours for observation.Had ct (computed tomography) and mri (magnetic resonance imaging) done which both reflected no change.Per neurologist, "suspect symptoms are related to recrudescence of previous punctate infarct earlier this month.The cause of stroke post procedure was thromboembolism.Patient was started on clopidogrel and atorvastatin when released to home.The outcome of this adverse event is ¿ongoing¿ at this moment.In physician¿s opinion, there were no any difficulties encountered during the procedure that could have contributed to the patient's stroke post procedure as the subject coil device was performed as intended.No other information was provided.
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 subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.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.Additional information provided by the customer indicated that the patient suffered from ischemic stroke about 9 hours post study procedure.The cause of stroke post procedure is thromboembolism.The patient had returned to baseline by the next day((b)(6) 2022) with the exception of minimal numbness.The patient returned to the er on (b)(6) 2022 with similar symptoms in addition to transient blurred vision in the left eye.The patient was kept under observation for 12 hours and underwent ct and mri scan which reflected no change.The patient was thus, started on 2 drugs- clopidogrel and atorvastatin before discharge.The device was confirmed to be in good condition during preparation/ prior to use on patient.Also, continuous flush was maintained throughout the procedure.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.The reported 'patient stroke' and ' patient vessel thrombosis is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• 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: 15984106
• Report Number: 3008881809-2022-00625
• Device Sequence Number: 6208671
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2025
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 23653033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White