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	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains in patient.
Event or Problem Description
During the stenting procedure, it was reported that the stent was suboptimally deployed with the one of the markers on the stent going in the wrong direction.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
During the stenting procedure, it was reported that the stent was suboptimally deployed with the one of the markers on the stent going in the wrong direction.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: 7787302
• Report Number: 3008881809-2018-00351
• Device Sequence Number: 227907
• Product Code: NJE
• UDI-Device Identifier: 07613252656142
• UDI-Public: 07613252656142
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: No Information
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: M003SZAS30150
• Device Lot Number: 20457513
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)
• Patient Age: 35 YR