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

Model Number	M003UZAS30150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet received for evaluation.
Event or Problem Description
It was reported that during the procedure the stent (subject device) deployed prematurely in the catheter.The device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was not confirmed because the packaging was not returned with the device.During visual inspection, the stent was returned deployed and intact.The introducer sheath and delivery wire were not returned.Functional testing was not performed because the defect was confirmed visually.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.As per the available information the device was prepared as per the dfu and continuous flush was maintained throughout the clinical procedure.The stent was returned deployed and was found to be intact.An assignable cause of procedural factors will be assigned to the reported/analyzed event of the stent deployed prematurely during use, 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 or Problem Description
It was reported that during the procedure the stent (subject device) deployed prematurely in the catheter.The device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11873812
• Report Number: 3008881809-2021-00218
• Device Sequence Number: 17235090
• Product Code: NJE
• UDI-Device Identifier: 07613327382228
• UDI-Public: 07613327382228
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: M003UZAS30150
• Device Catalogue Number: M003UZAS30150
• Device Lot Number: 22081299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1