MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 3.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ35200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	08/18/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during stenting procedure with the subject device and a non-stryker device, both devices thrombosed.Administration of pharmacological agents to clear the clots was performed.The patient was placed in palliative care until death occured 3 days post-procedure.The physician has established the relationship to the subject device as serious, expected, related.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, thrombosis and death are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that during stenting procedure with the subject device and a non-stryker device, both devices thrombosed.Administration of pharmacological agents to clear the clots was performed.The patient was placed in palliative care until death occured 3 days post-procedure.The physician has established the relationship to the subject device as serious, expected, related.

• Brand Name: NEUROFORM 3 EZ 3.5 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6147449
• Report Number: 3008881809-2016-00288
• Device Sequence Number: 509823
• Product Code: NJE
• UDI-Device Identifier: 04546540697806
• UDI-Public: (01)04546540697806(17)180228(10)18330260
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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: 02/28/2018
• Device Catalogue Number: M003N3EZ35200
• Device Lot Number: 18330260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 03/01/2017
• 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: ENTREPRISE STENT (B)(4)
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention