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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SURPASS EVOLVE FLOW DIVERTER INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR SURPASS EVOLVE FLOW DIVERTER INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS32525
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Loss of Vision (2139); Dysphasia (2195); Shaking/Tremors (2515); Taste Disorder (4422); Epistaxis (4458); Partial Hearing Loss (4472); Swelling/ Edema (4577)
Event Date 09/23/2020
Event Type  Injury  
Event Description
A patient called to report that she is experiencing an adverse event as a result of her implant ever since the implant date. A reporter went on saying that the toxicity effect from the device is getting into her blood stream. She said that she was told she has a high level of chromium in her system. As a result of these toxicity, she said she is experiencing, memory loss, shaking, brain swelling, face swelling, hearing loss, vision loss, nose bleeding, change of taste in her mouth and her throat hurts. All these symptoms are restricted to her right part of her face and brain. (b)(4).
 
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Brand NameSURPASS EVOLVE FLOW DIVERTER
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR
MDR Report Key13677717
MDR Text Key286767929
Report NumberMW5107911
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberFDS32525
Device Catalogue NumberFDS32525
Device Lot Number22240714
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No

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