MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SURPASS EVOLVE 4.0MMX X 12MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS40020

Device Problems Defective Device (2588); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 05/10/2022

Event Type  Injury  

Event Description

Patient was in interventional radiology for a neuro coiling procedure and when gaining access to the patient's lica via the femoral artery, the physician stopped advancing because it was not in the correct location.When attempting to resheath the stent it was deployed in the wrong location.Several attempts to retrieve the stent was attempted but unsuccessful due to the delivery wire becoming detached from the resheathing pad.The device is deigned to be retrievable but failed.The procedure continued with placing an additional stent in the originally intended location.Once the patient was awoken in the ir, the pupils were not responsive and right side was flaccid.The emergent stroke therapy began.The device was occluded by blood clots which is a known risk of the procedure.Fda safety report id# (b)(4).

• Brand Name: SURPASS EVOLVE 4.0MMX X 12MM
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 14547630
• MDR Text Key: 293147332
• Report Number: MW5109981
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 23249710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White