MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003SZAS40240C

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported during a clinical study that the patient suffered a transient ischemic attack (tia) approximately 2.5 years post procedure located in the right middle cerebral artery bifurcation with possible relation to the reported stent device.The patient was given medication heparin 4000 iu.The event resolved without sequelae 2 days later.No other information is available.

Event Description

It was reported during a clinical study that the patient suffered a transient ischemic attack (tia) approximately 2.5 years post procedure located in the right middle cerebral artery bifurcation with possible relation to the reported stent device.The patient was given medication hepatin 4000 iu.The event resolved without sequelae 2 days later.No other information is available.

Manufacturer Narrative

The device was not returned as it remains implanted in the patient.No visual or functional testing was performed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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.This is one (1) of two (2) mdr's submitted.H3 other text: device remains implanted in patient.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM NO TIP- IDE
• 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: 11359179
• MDR Text Key: 232856760
• Report Number: 3008881809-2021-00092
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: M003SZAS40240C
• Device Lot Number: 18429026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEUROFORM ATLAS STENT (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR