MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45015
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device is implanted in the patient.
Event or Problem Description
It was reported that the subject flow diverter was successfully implanted in a patient to treat saccular aneurysm in right ica-clinoid (c5 segment) in a patient on (b)(6) 2022.18 months post procedure on (b)(6) 2023 dsa (digital subtraction angiography) showed fishmouth deformity at distal stent margin resulting in medical management and balloon angioplasty retreatment of the right ica (internal carotid artery) on 21-jun-2023.It is reported that the adverse event (ae) is probably related to the study procedure and the study device.The rationale for relationship to study device is indicated as " associated with distal margin of stent.Change in stent contour between treatment and follow up".No further information is available.
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 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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.The patient was a 25 yrs female, with past medical history severe headache/migraine, pituitary adenoma, non-smoker, with a target saccular aneurysm at right internal carotid artery-clinoid, parent artery stenosis 0-25%.Initial implant completely covered aneurysm neck, and the device successfully implanted.No device deficiencies were reported.Follow up showed fishmouthing deformity (narrowing of 25-50%) at distal stent margin resulting in angioplasty of the right ica resulting in medical management and balloon angioplasty re-treatment, which reported a successful outcome.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported issue ¿stent tapering¿.
Event or Problem Description
It was reported that the subject flow diverter was successfully implanted in a patient to treat saccular aneurysm in right ica-clinoid (c5 segment) in a patient on (b)(6) 2022.18 months post procedure on (b)(6) 2023 dsa (digital subtraction angiography) showed fishmouth deformity at distal stent margin resulting in medical management and balloon angioplasty retreatment of the right ica (internal carotid artery) on (b)(6) 2023.It is reported that the adverse event (ae) is probably related to the study procedure and the study device.The rationale for relationship to study device is indicated as " associated with distal margin of stent.Change in stent contour between treatment and follow up".No further information is available.Additional information received on 2-apr-2024, reported that there was 25-50% percentage of stenosis due to subject stent fishmouthing and the patient was on longer than usual dapt regime (dual antiplatelet therapy).The aneurysm was resolved.No intimal hyperplasia and no reduction in the blood flow due to the reported event.The retreatment procedure was completed successfully.

• Brand Name: SURPASS EVOLVE 4.5MM X 15MM - 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: 19008789
• Report Number: 3008881809-2024-00140
• Device Sequence Number: 13121195
• Product Code: OUT
• UDI-Device Identifier: 07613327375244
• UDI-Public: 07613327375244
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: FDS45015
• Device Lot Number: 22643766
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• 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: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female