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

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).

• Brand Name: SURPASS EVOLVE FLOW DIVERTER
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 13677717
• MDR Text Key: 286767929
• Report Number: MW5107911
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FDS32525
• Device Catalogue Number: FDS32525
• Device Lot Number: 22240714
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 52 KG