MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphasia (2195); Encephalitis (2429); Cerebral Edema (4403); Speech Disorder (4415)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer as the subject device was implanted inside the patient's vasculature.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient to treat aneurysm on (b)(6) 2021.Post procedure on the same day patient had encephalopathy with expressive dysphasia and was apprehensive to repeat more complex sentences.The adverse event was reported to be resolved/recovered on (b)(6) 2021.Cta diagnostic tests performed indicates mild left hemispheric edema and mild contrast staining.On (b)(6) 2022, the imr (designated cec member) has assessed that the expressive dysphasia with apprehension to repeat more complex sentences in the patient was due to contrast induced encephalopathy and had possible relation to the subject flow diverter, the procedure, the dual antiplatelet therapy and other devices used during the procedure.No other information is available.
Additional Manufacturer Narrative
D4: lot number: corrected (from 22178110 to 22178110r).Due to the automated mes (manufacturing execution 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.The imr (independent medical review) has assessed contrast-induced encephalopthy to be possibly related to the study device (subject flow diverter stent).Diagnostic tests performed indicates ¿mild left hemispheric odema and mild contrast staining".Patient was provided with concomitant medication, however details of the drugs are not specified.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to as reported 'patient neurological deficit' and 'patient complication' for this complaint.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient to treat aneurysm on (b)(6) 2021.Post procedure on the same day patient had encephalopathy with expressive dysphasia and was apprehensive to repeat more complex sentences.The adverse event was reported to be resolved/recovered on (b)(6) 2021.Cta diagnostic tests performed indicates mild left hemispheric edema and mild contrast staining.On (b)(6) 2022, the imr (designated cec member) has assessed that the expressive dysphasia with apprehension to repeat more complex sentences in the patient was due to contrast induced encephalopathy and had possible relation to the subject flow diverter, the procedure, the dual antiplatelet therapy and other devices used during the procedure.No other information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 14334552
• Report Number: 3008881809-2022-00212
• Device Sequence Number: 17464177
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170024/S003
• 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): 09/28/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 22178110R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White