MAUDE Adverse Event Report: STRYKER NEUROVASCULAR STRYKER NEUROFORM ATLAS STENT 4.5MM X 21MM; INTRACRANIAL COIL-ASSIST STENT

Catalog Number M003UZAS45210

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/23/2020

Event Type  Injury  

Event Description

A 4.5mm x 21mm neuroform atlas stent advanced over the wire and stent dislodged from delivery system midway in catheter.Delivery system had to be pulled back over the wire pulling the dislodged stent along until it was removed from the catheter and expanded in the 'w" touhy.The stent was lodged into the bleedback needle and not embolized inside the patient's vasculature.Fda safety report id # (b)(4).

• Brand Name: STRYKER NEUROFORM ATLAS STENT 4.5MM X 21MM
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 10698679
• MDR Text Key: 212381865
• Report Number: MW5097311
• Device Sequence Number: 1
• Product Code: QCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003UZAS45210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• 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 Outcome(s): Required Intervention