MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient for treatment of aneurysm in left internal carotid artery-cavernous (c4 segment) on (b)(6) 2021 which completely covered the aneurysm neck.Post procedure on (b)(6) 2021 the patient had a migraine headache where the headache was typically slow in onset along with dizziness.It was reported that this typical headache was consistent with pre-treatment migraine symptoms in the patient.As per site reporting the patient was prescribed benadryl 25mg once iv, reglan 5mg once iv, and haldol 2.5mg once iv.The patient recovered from migraine headache on (b)(6) 2021.Ct diagnostic tests performed came back negative.On (b)(6) 2022, the imr (designated cec member) has assessed the migraine headache in the patient had possible relation to the subject flow diverter and an underlying condition or disease.No other information is available.
Additional Manufacturer Narrative
The device is not available to the manufacturer as the subject device was implanted inside the patient's vasculature.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.B5 executive summary - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Post procedure with the subject flow diverter patient complaints of migraine - for which benadryl 25mg once iv, reglan 5mg once iv, and haldol 2.5mg once iv were given as per site reporting in edc was administered.Based on the information provided in the complaint, there was no surgical delay reported; however medical intervention was required.Later on 21st-july-2022, it was reported that patient reports significant worsening headache compared to what they had in the past.Does not feel as bad as episodes prior to aneurysm diagnosis and patient is taking acetaminophen without much improvement of symptoms.Patient is recommended to present for re-evaluation if there is worsening or no improvement.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 this complaint.
Event or Problem Description
It was reported that in the clinical trial the subject flow diverter was implanted in a patient for treatment of aneurysm in left internal carotid artery-cavernous (c4 segment) on (b)(6) 2021 which completely covered the aneurysm neck.Post procedure on (b)(6) 2021 the patient had a migraine headache where the headache was typically slow in onset along with dizziness.It was reported that this typical headache was consistent with pre-treatment migraine symptoms in the patient.As per site reporting the patient was prescribed benadryl 25mg once iv, reglan 5mg once iv, and haldol 2.5mg once iv.The patient recovered from migraine headache on (b)(6) 2021.Ct diagnostic tests performed came back negative.On(b)(6) 2022, the imr (designated cec member) has assessed the migraine headache in the patient had possible relation to the subject flow diverter and an underlying condition or disease.No other information is available.According to the information received on 21st-july-2022, it was reported that patient reports significant worsening headache compared to what they had in the past.Patient does not feel as bad as episodes prior to aneurysm diagnosis.Patient is taking acetaminophen without much improvement of symptoms.Patient is recommended to present for re-evaluation if there is worsening or no improvement.It was assessed by the cec member that the worsening headache has a possible relationship to study device (subject flow diverter).

• Brand Name: SURPASS EVOLVE 4.0MM X 25MM - 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: 14319598
• Report Number: 3008881809-2022-00210
• Device Sequence Number: 17442617
• Product Code: OUT
• UDI-Device Identifier: 07613327375213
• UDI-Public: 07613327375213
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/31/2022

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: 09/10/2023
• Device Model Number: FDS40025
• Device Catalogue Number: FDS40025
• Device Lot Number: 22451798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White