MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5 X 30MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003N3EZ45300
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device implanted.
Event or Problem Description
It was reported that once the stent was deployed, one of the distal markers looked out of alignment.No patient consequences were reported due to this event.No additional information was provided.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, there may have been anatomical or procedural factors present during the clinical procedure, which may have contributed to the as reported event; however, this cannot be definitively determined.As a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable was assigned to the as reported issue ro marker band misaligned.
Event or Problem Description
It was reported that once the stent was deployed, one of the distal markers looked out of alignment.No patient consequences were reported due to this event.No additional information was provided.

• Brand Name: NEUROFORM 3 EZ 4.5 X 30MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8685459
• Report Number: 3008881809-2019-00169
• Device Sequence Number: 2292859
• Product Code: NJE
• UDI-Device Identifier: 04546540697882
• UDI-Public: 04546540697882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 11/11/2021
• Device Catalogue Number: M003N3EZ45300
• Device Lot Number: 20127048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1