MAUDE Adverse Event Report: STRYKER NEUROVASCULAR WINGSPAN 100812524, 20900398 3.0X15, 14-300CM EXCHANGE; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number SEE ATTACHED SHEET

Device Problem Off-Label Use (1494)

Patient Problems Stroke/CVA (1770); Perforation of Vessels (2135)

Event Date 02/20/2021

Event Type  Death  

Event Description

Vessel perforation during stent placement catheterization wire perforation of vessel during stent implant, stent is an hde device.Patient treated with endovascular therapy for stroke patient had repeat stroke in icu requiring repeat endovascular stroke therapy.Event occurred on second treatment.Medically medicated off label use of hde device, device approved for intracranial stenosis but typically not in acute setting of ongoing stroke event not related to stent but deployment wire.

• Brand Name: WINGSPAN 100812524, 20900398 3.0X15, 14-300CM EXCHANGE
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR
• MDR Report Key: 11541382
• MDR Text Key: 241786238
• Report Number: MW5100148
• Device Sequence Number: 1
• Product Code: NJE
• 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: 03/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE ATTACHED SHEET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 53