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

Catalog Number	FDSE45020
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a day after procedure, a cortical infarction was detected on diffusion-weighted imaging.Symptoms were mild, and the patient was discharged.10 days post-procedure patient was re-admitted with transient ischemic attack (tia) symptoms.Transfemoral cerebral angiography (tfca) imaging showed internal carotid artery (ica) artery thrombus and subject device fish-mouthing.Another surgery of thrombectomy was performed but was unsuccessful.Medications tirofiban were administered intravenously (iv) and intra-arterially (ia).Patient presented with arm weakness.2 days post- thrombectomy procedure, symptoms progressed to lower extremity weakness.More ica thrombus & severe fish mouthing and second ia thrombectomy attempt was made but was unsuccessful.Additional ia tirofiban was administered.The patient was transferred to another hospital.Physician gave feedback that the subject device fish mouthing has occurred due to the barreling of the stent, because of the morphology of the aneurysm.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added d4 gtin - added due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject stent was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 states "physician's feedback: fds fish mouthing has occurred due to the barreling of the stent, because of the morphology of the aneurysm".It is most likely that anatomical factors caused the reported 'stent tapering' but as the device was not returned for analysis this cannot be confirmed.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient vessel thrombosis¿ and 'patient tia (transient ischemic attack)' 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.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 a day after procedure, a cortical infarction was detected on diffusion-weighted imaging.Symptoms were mild, and the patient was discharged.10 days post-procedure patient was re-admitted with transient ischemic attack (tia) symptoms.Transfemoral cerebral angiography (tfca) imaging showed internal carotid artery (ica) artery thrombus and subject device fish-mouthing.Another surgery of thrombectomy was performed but was unsuccessful.Medications tirofiban were administered intravenously (iv) and intra-arterially (ia).Patient presented with arm weakness.2 days post- thrombectomy procedure, symptoms progressed to lower extremity weakness.More ica thrombus & severe fish mouthing and second ia thrombectomy attempt was made but was unsuccessful.Additional ia tirofiban was administered.The patient was transferred to another hospital.Physician gave feedback that the subject device fish mouthing has occurred due to the barreling of the stent, because of the morphology of the aneurysm.No further information is available.

• Brand Name: SURPASS ELITE FDS 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: 22166003
• Report Number: 3008881809-2025-00324
• Device Sequence Number: 9200127
• Product Code: OUT
• UDI-Device Identifier: 07613327582925
• UDI-Public: (01)07613327582925(17)270523(10)24981374
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FDSE45020
• Device Lot Number: 24981374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2024
• 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: EXCELSIOR XT-27 MICROCATHETER (STRYKER).; SHUTTLE GUIDING SHEATH (COOK MEDICAL).; SOFIA CATHETER (MICROVENTION).; SYNCHRO SELECT GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female