MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP- HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number M003SZAS30150

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

Patient Problems Paresis (1998); Numbness (2415); Obstruction/Occlusion (2422); Ischemia Stroke (4418)

Event Date 11/20/2022

Event Type  Injury  

Event Description

It was reported that during the basilar tip aneurysm procedure, the subject stent was deployed successfully.Post procedure patient had ischemic stroke (right side hemiparesis) and imaging showed the subject stent was occluded.Therefore, retreatment (endovascular treatment - thrombectomy) and medication were required.Patient condition is better but still in hospital.According to the site the adverse event had a causal relationship with the procedure, a possible relationship with the flow diverting stent, subject stent device and dapt.

Manufacturer Narrative

This 3 out 3 mdr reports.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.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.Additional information provided by the customer indicated the patient suffered an ischemic stroke post procedure.Retreatment was required, and patient remains in hospital.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported 'patient stroke'.Device remains implanted.

Event Description

It was reported that during the basilar tip aneurysm procedure, the subject stent was deployed successfully.Post procedure patient had ischemic stroke (right side hemiparesis) and imaging showed the subject stent was occluded.Therefore, retreatment (endovascular treatment - thrombectomy) and medication were required.Patient condition is better but still in hospital.According to the site the adverse event had a causal relationship with the procedure, a possible relationship with the flow diverting stent, subject stent device and dapt.Update: additional information received on 26-mar-2023 reported that there is ae#2 (numbness of the right hand (the patient experienced the numbness of the right hand.The right hand feels cold and icy to the touch).According to the site the adverse event had a possible relationship with the procedure, with the flow diverting stent, other stryker stent (subject atlas stent) device, and dapt (dual anti-platelet therapy).Outcome is recovered/resolved.No additional information is available.

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 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.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.Additional information provided by the customer indicated the patient suffered an ischemic stroke post procedure.Retreatment was required, ia alteplase was administered directly into the thrombus and patient remained in hospital.Two months later numbness was reported.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported 'patient stroke' and 'patient complication'.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- HDE
• 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: 16005848
• MDR Text Key: 305720171
• Report Number: 3008881809-2022-00634
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 07613252656142
• UDI-Public: 07613252656142
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M003SZAS30150
• Device Catalogue Number: M003SZAS30150
• Device Lot Number: 21805913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: AXS CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LS PLUS LONG SHEATH (STRYKER); EVOLVE FLOW DIVERTING STENT SYSTEM (STRYKER); EXCELSIOR XT 27 MICROCATHETER (STRYKER)
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 56 YR
• Patient Sex: Female