MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number	M003SZAS40240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/27/2018
Type of Reportable Event	Serious Injury
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 as well as a functional evaluation could not be performed.The reported stent thrombosis is a known risk associated with endovascular procedures and is listed as such in the device directions for use.Therefore, an assignable cause of known inherent risk of device has been assigned to the reported event.The device remains in patient.
Event or Problem Description
During the stent assisted coil embolization procedure, it was reported that thrombosis was noticed within the stent.Therefore, intraarterial aggrastat was provided to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP
• Common Device Name: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8351475
• Report Number: 3008881809-2019-00047
• Device Sequence Number: 16707739
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2023
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 20584378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/19/2019
• 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: TARGET COIL (STRYKER); TARGET COIL (STRYKER); TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 170