MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS30240
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during stent-assisted coil embolization of an aneurysm located in the anterior communicating artery, the subject stent was used with a microcatheter in extremely tortuous anatomy.The physician took the microcatheter very far distal and pulled the system back to release any built-up tension.When the physician began to deploy the subject stent, the microcatheter unexpectedly moved proximal to the aneurysm.The physician did not feel comfortable to deploy the stent in the new location since the stent would be too small for the vessel size.Partially deployed subject stent was corked into the microcatheter and both the stent and microcatheter were safely pulled back and retrieved successfully without leaving damage to the vessel.Another stent and microcatheter was used to complete the procedure successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed since the batch remains unknown; however, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as functional testing could not be performed.Based on the additional information provided, the subject device was confirmed to be in a good condition after unpacking and appears to have been used as per the direction for use (dfu).The anatomy was described as extremely tortuous which is likely to have contributed to the reported event.An assignable cause of procedural factors was assigned to the reported event 'nv ¿ stent partial deployment' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during stent-assisted coil embolization of an aneurysm located in the anterior communicating artery, the subject stent was used with a microcatheter in extremely tortuous anatomy.The physician took the microcatheter very far distal and pulled the system back to release any built-up tension.When the physician began to deploy the subject stent, the microcatheter unexpectedly moved proximal to the aneurysm.The physician did not feel comfortable to deploy the stent in the new location since the stent would be too small for the vessel size.Partially deployed subject stent was corked into the microcatheter and both the stent and microcatheter were safely pulled back and retrieved successfully without leaving damage to the vessel.Another stent and microcatheter was used to complete the procedure successfully.There were no clinical consequences to the patient.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM 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: 7539234
• Report Number: 3008881809-2018-00240
• Device Sequence Number: 2413255
• Product Code: NJE
• UDI-Device Identifier: 07613252656166
• UDI-Public: 07613252656166
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 07/25/2018

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: Health Professional
• Device Catalogue Number: M003SZAS30240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: XT-17 MICROCATHETER (STRYKER)