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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS45015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Visual Disturbances (2140)
Event Date 08/18/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported in the clinical study that 16 days post successful procedure with the subject flow diverter stent, the patient experienced bilateral visual disturbances. The visual disturbances consisted of blurry vision and flashes of light and were associated with non serious headaches. The visual disturbances resolved on the same day and non serious headaches were reported to be resolving. No intervention was performed due to this event. No other information is available.
 
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Brand NameSURPASS EVOLVE 4.5MM X 15MM - 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 Key12580041
MDR Text Key274921080
Report Number3008881809-2021-00414
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,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFDS45015
Device Catalogue NumberFDS45015
Device Lot Number22517711
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
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: 10/05/2021 Patient Sequence Number: 1
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