MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Thrombosis/Thrombus (4440)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that a stent implantation procedure was performed in a patient for intracranial aneurysm in left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2022.Intraprocedural imaging was performed post subject flow diverter stent implantation.The core lab report for the thromboembolic assessment (te) indicates ¿non-occlusive thrombus in parent artery within the subject flow diverter stent ¿.Furthermore the core lab commented that ¿possibly small amount of thrombus in dissection of parent artery within subject flow diverter stent¿.It was assessed that subject flow diverter stent was fully apposed to the parent artery.However the core lab commented ¿dissection of parent artery within stent likely caused by a non- stryker intermediate catheter¿.The procedure was completed successfully.No more information is available.
Additional Manufacturer Narrative
Due to the automated mes 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.An assignable cause of anticipated procedural complication will be assigned to the reported 'patient headache serious', and ¿patient vessel thrombosis¿, 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 labelling and/or risk documentation files.
Event or Problem Description
It was reported that a stent implantation procedure was performed in a patient for intracranial aneurysm in left internal carotid artery-ophthalmic (c6 segment) on (b)(6) 2022.Intraprocedural imaging was performed post subject flow diverter stent implantation.The core lab report for the thromboembolic assessment (te) indicates ¿non-occlusive thrombus in parent artery within the subject flow diverter stent ¿.Furthermore the core lab commented that ¿possibly small amount of thrombus in dissection of parent artery within subject flow diverter stent¿.It was assessed that subject flow diverter stent was fully apposed to the parent artery.However the core lab commented ¿dissection of parent artery within stent likely caused by a non- stryker intermediate catheter¿.The procedure was completed successfully.No more information is available.25-aug-2022: additional information received reported that there was suspected platelet aggregation (early thrombus formation) within the ophthalmic artery.There was no overt evidence of thrombus within the subject flow diverter stent itself.There were no concerns for dissection or injury to the vessel.The issue was resolved on the same day ((b)(6) 2022) with giving a dose of intra-arterial integrillin.Once this was given the ophthalmic artery was patent without concerns.The stent thrombosis is causally related to the study procedure and is possibly related to the study device (subject flow diverter stent).However it was noted that the stent thrombosis could also be related to balloon angioplasty performed during the procedure.13-sep-2022: additional information received reported that the patient had mild headache which started on 27-may-2022 and was resolved on the same day with medication.The patient presented to outside ed with stabbing headache that comes and goes and underlying global headache on (b)(6) 2022.The patient was given iv fluids, compazine, benadryl and magnesium medications, patient improved the headache was resolved the same day ((b)(6) 2022) and discharged home.The headache was possibly related to the study procedure, an underlying condition or disease and the study device (subject flow diverter).

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - 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: 15291435
• Report Number: 3008881809-2022-00412
• Device Sequence Number: 2504691
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/07/2022

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: 09/09/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22451788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOPHIA 5F CATHETER (MEDTRONIC'S)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White