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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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.
 
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Brand NameSURPASS EVOLVE 3.25MM X 20MM - CE
Type of DeviceINTRACRANIAL 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 Key12425538
MDR Text Key270335649
Report Number3008881809-2021-00360
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFD32520
Device Lot Number22047741R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2021 Patient Sequence Number: 1
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