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 Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the stent (subject device) was missing, after further investigation, it is suspected that microcatheter used was too big and stent (subject device) had possibly deployed at the base of the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.The device was returned detached and the reported lot number was confirmed from the returned packaging.During visual inspection, there were no anomalies noted to the stent delivery wire or the introducer sheath.The deployed stent was not returned.A functional test could not be performed as the stent had been deployed.The stent delivery wire moved freely within the introducer sheath.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.As per the additional information, the subject stent was deployed inside a microcatheter for delivery.As per the stent dfu, the device is compatible with stryker neurovascular microcatheters.It is probable that the stent was deployed inside the microcatheter as it is not a compatible device.An assignable cause of user error will be assigned to the reported event, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the procedure, the stent (subject device) was missing, after further investigation, it is suspected that microcatheter used was too big and stent (subject device) had possibly deployed at the base of the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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 ; IE NA
• MDR Report Key: 9900068
• Report Number: 3008881809-2020-00081
• Device Sequence Number: 2807944
• Product Code: NJE
• UDI-Device Identifier: 07613327382228
• UDI-Public: 07613327382228
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2024
• Device Model Number: M003UZAS30150
• Device Catalogue Number: M003UZAS30150
• Device Lot Number: 21458712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELOCITY DELIVERY MICROCATHETER (PENUMBRA)