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

Catalog Number M003EZAS40240

Device Problem Premature Activation (1484)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

This is first of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during procedure of the anterior cerebral artery (aca), the subject device stent was released in microcatheter during insertion.The subject device was removed.There were no reported clinical consequences to the patient due to this event.No other information was provided.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the returned device was visually inspected that the stent was returned in its deployed state and noted to have some slight deformation.A functional test was not performed as the stent had been deployed.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 deformed stent was returned in its deployed state confirming the event.It is probable that there were difficulties in advancing the stent through the catheter/ during insertion, causing the premature stent deployment and damage to the ttent.An assignable cause of procedural factors will be assigned to the reported and analysed 'stent deployed prematurely during use' and the analysed 'stent deformed', 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.

Event Description

It was reported that during procedure of the anterior cerebral artery (aca), the subject device stent was released in microcatheter during insertion.The subject device was removed.There were no reported clinical consequences to the patient due to this event.No other information was provided.

• Brand Name: NEUROFORM ATLAS 4.0MM X 24MM 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
• MDR Report Key: 10383041
• MDR Text Key: 202213273
• Report Number: 3008881809-2020-00234
• 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: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2024
• Device Catalogue Number: M003EZAS40240
• Device Lot Number: 21226580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/08/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER SL-10 (STRYKER)
• Patient Age: 49 YR