MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS45300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device analysis was performed on the returned sample, and there were no anomalies noted to the device.The stent.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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 is probable friction was felt advancing, as described, and this caused the reported difficulty to advance within the microcatheter and caused the stent to prematurely detach during use, therefore a cause of procedural factors will be assigned to the investigation.
Event or Problem Description
Analysis of the returned device found that the stent was prematurely deployed during use.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.5 X 30MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9169990
• Report Number: 3008881809-2019-00306
• Device Sequence Number: 11733707
• Product Code: NJE
• UDI-Device Identifier: 07613252656241
• UDI-Public: 07613252656241
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/08/2019

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: 01/23/2024
• Device Catalogue Number: M003SZAS45300
• Device Lot Number: 21170011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1