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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDS40017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphasia (2195); Speech Disorder (4415); Ischemia Stroke (4418)
Event Date 09/16/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that the subject flow diverter was used in a clinical trial to treat a left internal carotid artery (lica) aneurysm successfully. Post procedure, the patient developed aphasia and mild dysarthria and an mri scan was done which showed small punctuate insular stroke due to small emboli. Mra showed patent lica stent and open distal vessels. Patient had a prolonged hospitalization due to event and was treated with medication. Event was reported to have resolved the next day and the patient was discharged. No other information is available.
 
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Brand NameSURPASS EVOLVE 4.0MM X 17MM - PMAS
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 Key12637231
MDR Text Key276582564
Report Number3008881809-2021-00438
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDS40017
Device Lot Number22452424
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 Received09/22/2021
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: 10/14/2021 Patient Sequence Number: 1
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