MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140)
Date of Event	06/05/2021
Type of Reportable Event	Serious Injury
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 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.While additional information originally stated the ¿event is not related to the study device.The justification provided for this change is ¿after gathering more information, the pi has stated that it is contralateral and not related.¿ cec (imr) decision with making this event possibly related to the evolve study device and also stryker accessory device.Complaint of visual scotoma in contralateral eye but no imaging available to exclude non-ocular causes.There was no diagnostic imaging performed after event, however a diagnostic test for antiplatelet efficacy was performed where the ¿pru level on (b)(6) 2021 results = 52¿.There were no associated symptoms reported, however the patient ¿reports intermittent left eye ¿flashing lights¿, ¿like a shooting star¿.The eye exam (b)(6) with the optometrist stated 'normal and no issues¿.On the (b)(6) visit ¿it has improved.¿ the patient outcome after the adverse event is that it is ongoing and indicated as ¿recovering/resolving¿.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.An assignable cause of anticipated procedural complication will be assigned to the reported event 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 with the directions for use, product labeling and/or risk documentation files.Device is implanted in patient.
Event or Problem Description
It was reported that post a successful procedure during a clinical trial for an aneurysm in the internal carotid artery-clinoid (c5 segment), the subject had visual disturbance.This was described as intermittent left eye flashing lights like a shooting star.The visual disturbances had no associated symptoms.On eye examination, a normal retina with no issues was found.A diagnostic test for antiplatelet efficacy was also performed where the pru level was 52.The event was reported as recovering/resolving.In the site physician's opinion, this event was not related to the subject flow diverter as it was contralateral.Cec adjudicated this event as possibly related to the subject flow diverter, long sheath, catheter and micro catheter.
Additional Manufacturer Narrative
Updated information from investigation conclusion: additional information received on the 30 mar 2022 indicates the 'adverse event (ae) - headache' is possibly related to the study procedure and is possibly related to the evolve flow diverter study device.The ae resulted in treatment.A concomitant or additional treatment was given due to this ae.
Event or Problem Description
It was reported that post a successful procedure during a clinical trial for an aneurysm in the internal carotid artery-clinoid (c5 segment), the subject had visual disturbance.This was described as intermittent left eye flashing lights like a shooting star.The visual disturbances had no associated symptoms.On eye examination, a normal retina with no issues was found.A diagnostic test for antiplatelet efficacy was also performed where the pru level was 52.The event was reported as recovering/resolving.In the site physician's opinion, this event was not related to the subject flow diverter as it was contralateral.Cec adjudicated this event as possibly related to the subject flow diverter, long sheath, catheter and micro catheter.Additional information received from the site on 05-apr-2022 confirmed that the headache was a non-serious in nature and tylenol 650 mg was prescribed per site entry.

• Brand Name: SURPASS EVOLVE 4.5MM X 17MM - 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: 12943679
• Report Number: 3008881809-2021-00510
• Device Sequence Number: 20047676
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/15/2022

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: 08/30/2023
• Device Model Number: FDS45017
• Device Catalogue Number: FDS45017
• Device Lot Number: 22422917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2020
• 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: AXS CATALYST 5 (STRYKER); AXS INFINITY LS (STRYKER); EXCELSIOR XT-27 (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White