MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer, as device is implanted in patient.

Event Description

It was reported that successful flow diverter stent placement procedure was performed on (b)(6) 2021 for m1-2 (middle cerebral artery m1-2 segment) aneurysm and under fluoroscopy stent cell apposition to vessel wall was confirmed.According to physician subject stent performed as intended.Patient was reported to have moderately tortuous vasculature and the aneurysm site was at a bent vessel and it was difficult to reach.On (b)(6) 2021, patient came to hospital with symptom of weakness.So angiogram was performed by physician which revealed occlusion of one of the vessel due to formation of thrombus which is the cause of delayed infarction (grade 2-3).Patient informed that he got astrazeneca vaccine 1 week ago (1 week before weakness).The physician suspected and investigated whether the cause was form vaccine (astrazeneca covid-19 vaccine) or surpass evolve stent.Additional information stated that physician is not sure about the reason of adverse event.Patient is on asa (acetylsalicylic acid), plavix and prevacid.The patient had antiplatelet aggregation test with good response and there is no platelet clot at stent.It is not reported, when they performed antiplatelet aggregation test.There was no failure of antiplatelet prophylactic regimen.The physician advised the patient to do physical therapy.Patient outcome is ongoing.

Event Description

It was reported that successful flow diverter stent placement procedure was performed on (b)(6) 2021 for m1-2 (middle cerebral artery m1-2 segment) aneurysm and under fluoroscopy stent cell apposition to vessel wall was confirmed.According to physician subject stent performed as intended.Patient was reported to have moderately tortuous vasculature and the aneurysm site was at a bent vessel and it was difficult to reach.On (b)(6) 2021, patient came to hospital with symptom of weakness.So angiogram was performed by physician which revealed occlusion of one of the vessel due to formation of thrombus which is the cause of delayed infarction (grade 2-3).Patient informed that he got astrazeneca vaccine 1 week ago (1 week before weakness).The physician suspected and investigated whether the cause was form vaccine (astrazeneca covid-19 vaccine) or surpass evolve stent.Additional information stated that physician is not sure about the reason of adverse event.Patient is on asa (acetylsalicylic acid), plavix and prevacid.The patient had antiplatelet aggregation test with good response and there is no platelet clot at stent.It is not reported, when they performed antiplatelet aggregation test.There was no failure of antiplatelet prophylactic regimen.The physician advised the patient to do physical therapy.Patient outcome is ongoing.

Manufacturer Narrative

D4 expiration date: added.H4 manufacturing date: added.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 is not available; therefore, functional testing as well as physical analysis cannot 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.It was reported that a patient was inserted surpass evolve and the procedure outcome was complete, patient looks good.The patient came to a hospital because of weakness, the doctor performed angiogram to check the vessel and found that 1 vessel was gone which is the cause of delayed infarction (grade 2-3).Patient informed that he got astrazeneca vaccine 1 week ago (1 week before weakness).Patient had antiplatelet aggregation test with good response, he also on asa, plavix and prevacid.The doctor suspected and investigated whether the cause was form vaccine or surpass evolve stent.Additional information indicates the event was resolved.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: SURPASS EVOLVE 3.25MM X 20MM - CE
• Type of Device: 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: 12425538
• MDR Text Key: 270335649
• Report Number: 3008881809-2021-00360
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Catalogue Number: FD32520
• Device Lot Number: 22047741R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AXS CATALYST5 MICROCATHETER (STRYKER).; EXCELSIOR XT-27 MICROCATHETER (STRYKER).; NEURONMAX INTERMEDIATE (PENUMBRA).; STRAIGTH GUIDEWIRE - SYNCHRO 014-200 (STRYKER).
• Patient Outcome(s): Disability; Other
• Patient Age: 42 YR
• Patient Sex: Male