MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE40012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject stent was successfully deployed into the patient¿s left internal carotid artery (ica) with minimal manipulation and no post-deployment processing needed.However, a few minutes after deployment, a clot developed at the distal end of the stent, obstructing flow into the a1 segment of the anterior cerebral artery.The physician confirmed that the patient was responsive to dual antiplatelet therapy (dapt) with brilinta and had no known metal allergies.To resolve the occlusion, the patient was administered a bolus dose and placed on a continuous infusion of either aggrastat or integrilin, which successfully dissolved the clot and restored blood flow within 30 minutes.There was a 35 minute procedural delay.The patient¿s condition improved, and was discharged from the hospital three days after the procedure, with no signs of neurological deficits.No additional information is available.
Additional Manufacturer Narrative
H5 labeled for single use - updated.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 was not available; therefore, a visual inspection as well as a functional evaluation could not 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.Based upon medical review, the harm observed in the 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 vessel thrombosis¿ and ¿patient vessel occlusion¿ 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.
Event or Problem Description
It was reported that the subject stent was successfully deployed into the patient¿s left internal carotid artery (ica) with minimal manipulation and no post-deployment processing needed.However, a few minutes after deployment, a clot developed at the distal end of the stent, obstructing flow into the a1 segment of the anterior cerebral artery.The physician confirmed that the patient was responsive to dual antiplatelet therapy (dapt) with brilinta and had no known metal allergies.To resolve the occlusion, the patient was administered a bolus dose and placed on a continuous infusion of either aggrastat or integrilin, which successfully dissolved the clot and restored blood flow within 30 minutes.There was a 35 minute procedural delay.The patient¿s condition improved and was discharged from the hospital three days after the procedure, with no signs of neurological deficits.No additional information is available.

• Brand Name: SURPASS ELITE FDS 4.0MM X 12MM - 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: 21778842
• Report Number: 3008881809-2025-00190
• Device Sequence Number: 15619307
• Product Code: OUT
• UDI-Device Identifier: 07613327582697
• UDI-Public: (01)07613327582697(17)271006(10)25221757
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• 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): 05/19/2025

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 Catalogue Number: FDSE40012
• Device Lot Number: 25221757
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown