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

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

Surpass evolve device moved after deployment inside the vessel.Serious concern regarding the competence of the technical specialists supporting the case.Lack of knowledge of flow diversion of the technical specialists and proctors supporting the case.Fda safety report id# (b)(4).

• Brand Name: SURPASS EVOLVE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR ; fremont CA 94538
• MDR Report Key: 10507359
• MDR Text Key: 206326706
• Report Number: MW5096476
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 92