MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003UZAS30210

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

Patient Problem Infarction, Cerebral (1771)

Event Date 10/07/2017

Event Type  Injury  

Manufacturer Narrative

This is the second of 2 reports.Subject device remains implanted.

Event Description

It was reported that 1-month post-procedure of stent-assisted coiling with two subject stents, the patient experienced ischemic stroke with regressive right paresis and slurred speech.Kardegic 75mg/day medication was stopped 15 days before the adverse event date.This adverse event of ischemic stroke was assessed as non-serious and was resolved, without sequelae the next day.

Event Description

It was reported that 1-month post-procedure of stent-assisted coiling with two subject stents, the patient experienced ischemic stroke with regressive right paresis and slurred speech.Kardegic 75mg/day medication was stopped 15 days before the adverse event date.This adverse event of ischemic stroke was assessed as non-serious and was resolved, without sequelae the next day.

Manufacturer Narrative

The intended use for the device was for treatment.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• Brand Name: NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10241786
• MDR Text Key: 197839030
• Report Number: 3008881809-2020-00196
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613327382211
• UDI-Public: 07613327382211
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: M003UZAS30210
• Device Catalogue Number: M003UZAS30210
• Device Lot Number: 19611386
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ALTAS STENT (STRYKER); NEUROFORM ALTAS STENT (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 49 YR