MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EZAS45210

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

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis therefore the visual and functional inspection could not be performed.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The risk of the reported event is covered in the device directions for use (dfu).The device was not returned.An assignable cause of anticipated procedural complication will be assigned to the as reported patient neurological deficit and patient vessel thrombosis 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.The device is not available to the manufacturer.

Event Description

Additional information was received on 01-apr-2022 that the ae2 worsening of the patient's neurological status was related to the subject stent.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The risk of the reported event is covered in the device directions for use (dfu).The reported event was unable to be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The device was not returned.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.

Event Description

Additional information was received on 01-apr-2022 that the ae2 worsening of the patient's neurological status was related to the subject stent.Update: received additional information on 04-apr-2023 that as per cec comment the (ae2 was related to subject stent) worsening of the neurological status by only one point on the nihss score is considered as normal fluctuation of the acute stroke and therefore not as a new adverse event, and the ae1 was updated to 4 days post flow diverter implantation procedure, patient had stroke due to the fd occlusion.Imaging revealed occlusion of the fd (thrombosis or occlusion with fish mouthing of the distal portion) per dsa (digital subtraction angiography) and left sylvian ischemic lesion related to carotid thrombus per mri (magnetic resonance imaging) for which percutaneous intervention and the patient recovered/resolved with sequelae.Patient was treated with agrastat infusion and aspiration.The reported event has a causal relationship to procedure, subject device, other stryker devices, and unlikely relationship to dapt (dual anti-platelet therapy).

• Brand Name: NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14109602
• MDR Text Key: 289266411
• Report Number: 3008881809-2022-00173
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P180031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 23111055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SURPASS EVOLVE FLOW DIVERTER STENT (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female