MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS40240

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Thrombus (2101)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported the during implantation of the stent (subject device) into the right posterior cerebral artery (pca), the patient suffered a stroke of the distal basilar artery.The physician performed a thrombectomy and blood circulation was restored.The physician suspects that the stroke occurred due to thrombus formation in the stent lumen at the top of the basilar artery.The patient is currently hospitalized with a mid-brain stroke of score 18 on national institutes of health stroke scale (nhiss).No further information is available.

Manufacturer Narrative

The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Based on the investigation results and available information an assignable cause of anticipated procedural complication was assigned to the as reported issue of patient stroke and thrombus formation since the issues are due to known physiological effects of the procedure and or/ patient condition noted with the direction for use, device labelling and/or risk documentation files.The subject device remains implanted in patient.

Event Description

It was reported the during implantation of the stent (subject device) into the right posterior cerebral artery (pca), the patient suffered a stroke of the distal basilar artery.The physician performed a thrombectomy and blood circulation was restored.The physician suspects that the stroke occurred due to thrombus formation in the stent lumen at the top of the basilar artery.The patient is currently hospitalized with a mid-brain stroke of score 18 on national institutes of health stroke scale (nhiss).No further information is available.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8510339
• MDR Text Key: 141795725
• Report Number: 3008881809-2019-00098
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (y/n): N
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 20296589
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR MICROCATHETER (STRYKER); EXCELSIOR MICROCATHETER (STRYKER)
• Patient Outcome(s): Hospitalization; Other; Required Intervention