MAUDE Adverse Event Report: STRYKER NEUROVASCULAR WINGSPAN; INTRACRANIAL NEUROVASCULAR STENT

Device Problem Off-Label Use (1494)

Patient Problem Death (1802)

Event Date 11/02/2018

Event Type  Death  

Event Description

Off label use of wingspan device, to treat stroke that happened a day before use of device.Fda safety report id# (b)(4).

• Brand Name: WINGSPAN
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 8590811
• MDR Text Key: 144459130
• Report Number: MW5086434
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 55