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

Catalog Number M003EZAS45210

Device Problems Structural Problem (2506); Migration (4003)

Patient Problems Paralysis (1997); Cognitive Changes (2551)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The subject device remained inside patient.

Event Description

It was reported that during one mca (middle cerebral artery) oa aneurysm procedure, the operator used the subject stent to assist the coil embolization.After placing the coil embolization, microcatheter and stent microcatheter to the location, the operator delivered the subject stent and deployed.During deployment, the proximal of the subject stent landed at bended area of the vessel and after completely deployment it could be seen that one of the three markers at proximal was far away from the other two.Continued to fill coils, and during delivery the operator found the coil protruded out to parent vessel (could not be judged it was because of the subject stent not properly attached to vessel wall, or the coil was advanced to go through the mesh of stent).Therefore, the coil was withdrawn and re-adjusted its position and delivered again to finish the procedure.One day after the procedure the patient had one side hemiplegia and mental confusion and was transferred to another hospital the next day for further treatment.Per physician's opinion patient's hemiplegia and mental confusion were caused by the surgery.

Event Description

It was reported that during one mca (middle cerebral artery) oa aneurysm procedure, the operator used the subject stent to assist the coil embolization.After placing the coil embolization, microcatheter and stent microcatheter to the location, the operator delivered the subject stent and deployed.During deployment, the proximal of the subject stent landed at bended area of the vessel and after completely deployment it could be seen that one of the three markers at proximal was far away from the other two.Continued to fill coils, and during delivery the operator found the coil protruded out to parent vessel (could not be judged it was because of the subject stent not properly attached to vessel wall, or the coil was advanced to go through the mesh of stent).Therefore, the coil was withdrawn and re-adjusted its position and delivered again to finish the procedure.One day after the procedure the patient had one side hemiplegia and mental confusion and was transferred to another hospital the next day for further treatment.Per physician's opinion patient's hemiplegia and mental confusion were caused by the surgery.

Manufacturer Narrative

D4 expiration date - added.H4 manufacturing date ¿updated.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 returned for analysis; therefore, physical as well as a functional testing could not be performed.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.The reported event is covered in the device direction 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.It was reported that during deployment, the proximal of the stent landed at bended area of the vessel and after completely deployment it could be seen that one of the three markers at proximal was far away from the other two.Continued to fill coils, and during delivery the operator found the coil protruded out to parent vessel(could not be judged it was because of the stent not properly attached to vessel wall, or the coil was advanced to go through the mesh of stent).So the operator withdrew the coil out and re-adjusted its position and delivered again to finish the procedure.Additional information provided by the customer indicates that the device was prepared as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The patients anatomy was moderately tortuous.It is probable that the stent may have been damaged or migrated during deployment in the bent area of the vessel, causing the subsequent coil protrusion through the stent which is likely to have caused or contributed to the reported patient stroke and patient neurological deficit.An assignable cause of procedural factors was assigned to this complaint, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• 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: 16518765
• MDR Text Key: 311035443
• Report Number: 3008881809-2023-00121
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M003EZAS45210
• Device Lot Number: 23809005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• 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: COILS (UNKNOWN MANUFACTURER); XT-17 MICROCATHETER (STRYKER)
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: Asian