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	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject device was used on (b)(6) 2025.There were no issues with the subject device during the procedure as the subject device was prepped per ifu.The patient was on dual anti platelet, no thromboembolic events during the procedure.Proximal end was malposed and after running the intermediate catheter through the deployed subject device, good apposition was noted and procedure was successfully completed.The patient did very well and was discharged on (b)(6) 2025.Post procedure on (b)(6) 2025, the patient developed stroke like symptoms and a mechanical thrombectomy was performed at another hospital with a different physician.An angiogram showed the subject device was occluded.Patient stopped taking their dual antiplatelet medications since being discharged on (b)(6) 2025 resulting in the formation of thrombus throughout the entire subject device and the thrombectomy.Based on the physician¿s opinion stated that the reported event due to the lack of dual antiplatelet therapy causing clot formation within the subject device.The patient is alive with deficits and is still in hospital being medically managed for hydrocephalus.
Additional Manufacturer Narrative
D4 expiration date ¿ added.D4 gtin- added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) 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 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.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.Based on the information provided in the complaint, an adverse event occurred post procedure.Medical intervention was required.Post procedure, the patient developed stroke like symptoms and a mechanical thrombectomy was performed hospitalization (the patient is alive with deficits and is still in hospital being medically managed for hydrocephalus) formation of thrombus throughout the entire subject stent.The physician who performed the thrombectomy believes it was not dr (b)(6) fault or elites fault per say, but rather due to the lack of dual antiplatelet therapy causing clot formation within the device.Patient had stopped taking their dual antiplatlet medications since being discharged 7/4 resulting in the formation of thrombus throughout the entire stent and the thrombectomy 6 days post op on (b)(6).Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment and does not require escalation to senior management.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vessel thrombosis¿ and ¿patient stroke¿ 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 device was used on (b)(6) 2025.There were no issues with the subject device during the procedure as the subject device was prepped per ifu.The patient was on dual anti platelet, no thromboembolic events during the procedure.Proximal end was malposed and after running the intermediate catheter through the deployed subject device, good apposition was noted and procedure was successfully completed.The patient did very well and was discharged on (b)(6) 2025.Post procedure on (b)(6) 2025, the patient developed stroke like symptoms and a mechanical thrombectomy was performed at another hospital with a different physician.An angiogram showed the subject device was occluded.Patient stopped taking their dual antiplatelet medications since being discharged on (b)(6) 2025 resulting in the formation of thrombus throughout the entire subject device and the thrombectomy.Based on the physician¿s opinion stated that the reported event due to the lack of dual antiplatelet therapy causing clot formation within the subject device.The patient is alive with deficits and is still in hospital being medically managed for hydrocephalus.

• 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: 22728278
• Report Number: 3008881809-2025-00428
• Device Sequence Number: 9051030
• 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): 08/21/2025

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): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT 5 INTERMEDIATE CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic