MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ40200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available.
Event or Problem Description
It was reported that while attempting to be resheathed in the introducer sheath, the subject stent appeared to get stuck when sheath was removed and prematurely deployed in the microcatheter hub.Procedure was completed successfully with another of the same device.No consequences to the patient was reported.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The cause of the reported issue could not be definitively determined.
Event or Problem Description
It was reported that while attempting to be resheathed in the introducer sheath, the subject stent appeared to get stuck when sheath was removed and prematurely deployed in the microcatheter hub.Procedure was completed successfully with another of the same device.No consequences to the patient was reported.

• Brand Name: NEUROFORM 3 EZ 4.0 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: 6191665
• Report Number: 3008881809-2016-00325
• Device Sequence Number: 866193
• Product Code: NJE
• UDI-Device Identifier: 04546540697837
• UDI-Public: (01)04546540697837(17)181231(10)18837255
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 12/31/2018
• Device Catalogue Number: M003N3EZ40200
• Device Lot Number: 18837255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/31/2017
• 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: XT-27 MICOCATHETER (STRYKER)