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	Headache (1880); Stenosis (2263)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is implanted in patient.
Event or Problem Description
It was reported that during a clinical trial procedure for a left ophthalmic saccular aneurysm in the internal carotid artery, the subject flow diverter was implanted successfully.Pre procedure imaging did not indicate any additional abnormalities.Procedure angiogram indicated 0-25% stenosis in the parent artery and in the subject flow diverter implanted which had no clinical significance to the patient.One day post procedure, the patient experienced non serious persistent ipsilateral headaches that were unrelieved by tylenol.Patient medication was changed to fioricet and the headaches resolved.No other information is available.
Event or Problem Description
It was reported that during a clinical trial procedure for a left ophthalmic saccular aneurysm in the internal carotid artery, the subject flow diverter was implanted successfully.Pre procedure imaging did not indicate any additional abnormalities.Procedure angiogram indicated 0-25% stenosis in the parent artery and in the subject flow diverter implanted which had no clinical significance to the patient.One day post procedure, the patient experienced non serious persistent ipsilateral headaches that were unrelieved by tylenol.Patient medication was changed to fioricet and the headaches resolved.No other information is available.
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint 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.Per the ae description ¿persistent left sided headaches unrelieved by tylenol no visual changes started fioricet¿.This is classified as a worsening focal ipsilateral headache by the site but not a suspected stoke event.Medication was given for the event, no other medical intervention is indicated in edc.Procedure angiogram indicates 0-25% stenosis (which is equivalent to no clinically significant stenosis).The reported 'patient parent vessel stenosis' and 'patient headache non-serious', are known and anticipated complications 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: 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: 12485706
• Report Number: 3008881809-2021-00386
• Device Sequence Number: 20105622
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/14/2022

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: 10/05/2023
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 22510830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White