MAUDE Adverse Event Report: STRYKER NEUROVASCULAR SURPASS STREAMLINE FLOW DIVERTER RADIOPAQUE MARKER FROM AXS CATALYST 5 LOT:22193; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number 5MM X 50MM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  malfunction  

Event Description

Patient was in for a 6mm aneurysm treatment.Two surpass streamline stents were used to treat the aneurysm.An extra small density was noted in a catheter.Both stents successfully placed.Suspected the surpass streamline flow diverter 5mmx50mm or the surpass streamline flow diverter 5mmx40mm detached from the deployment mechanism.Determined the density/radio plaque marker was in axs catalyst 5.No harm to patient.Axs catalyst detached from deployment mechanism and into patient¿s body, was able to be retrieved.It was from 1 of models¿ below.

• Brand Name: SURPASS STREAMLINE FLOW DIVERTER RADIOPAQUE MARKER FROM AXS CATALYST 5 LOT:22193
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 10894437
• MDR Text Key: 218241292
• Report Number: MW5098047
• 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: Unknown
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5MM X 50MM
• Device Lot Number: 22098131
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 100