MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2019
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.During the analysis of the returned device, it was revealed that the stent delivery wire was kinked, and the stent deployed prematurely during use.Functional testing could not be performed as the stent was not returned.Additional information indicates no damage was noted to the device packaging.It is likely that the stent was deployed prematurely during use and deployment was not noted.A most probable assignable cause of handling damage will be assigned to the reported and analyzed event, as the issue is due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.
Event or Problem Description
During the analysis of the returned device, it was revealed that the stent was deployed prematurely during use.No clinical consequences reported to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 15MM 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: 8375528
• Report Number: 3008881809-2019-00057
• Device Sequence Number: 2010269
• Product Code: NJE
• UDI-Device Identifier: 07613252656142
• UDI-Public: 07613252656142
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• 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): 02/27/2019

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: 08/05/2023
• Device Catalogue Number: M003SZAS30150
• Device Lot Number: 20766771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1