MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
Post procedure with the subject flow diverter on (b)(6) 2022 patient developed pain in groin and had continued headaches.Patient has past history of headaches.The pain in head and groin continued to persist at 1 month follow up visit as well.Patient has a medical history of severe headache/migraine, depression, anxiety and pain.Adverse event out come is indicated as not recovered/not resolved.It was indicated that no treatment was required.The adverse event is indicated to be possibly related to the study procedure, the study device and an underlying condition or disease.
Event or Problem Description
Post procedure with the subject flow diverter on (b)(6) 2022 patient developed pain in groin and had continued headaches.Patient has past history of headaches.The pain in head and groin continued to persist at 1 month follow up visit as well.Patient has a medical history of severe headache/migraine, depression, anxiety and pain.Adverse event out come is indicated as not recovered/not resolved.It was indicated that no treatment was required.The adverse event is indicated to be possibly related to the study procedure, the study device and an underlying condition or disease.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) 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.Additional information provided by the customer indicated the pain was general pain per site, the subject had past medical history of general pain.The groin pain was possibly related to the study procedure.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient discomfort/pain¿ and ¿patient headache non-serious¿ 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.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 17620829
• Report Number: 3008881809-2023-00436
• Device Sequence Number: 20678985
• Product Code: OUT
• UDI-Device Identifier: 07613327375251
• UDI-Public: 07613327375251
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• 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): 10/04/2023

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: 12/14/2023
• Device Catalogue Number: FDS45020
• Device Lot Number: 22643758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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: 60 YR
• Patient Sex: Female