MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS40210
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during the procedure, the stent was partially deployed; however, the microcatheter slipped back to a position not suitable for implanting.The physician was able to pull back the microcatheter and partially deployed stent into the intermediate support microcatheter and both products were removed from the patient¿s body.Another stent was used to complete the procedure.There were no clinical consequences reported due to this event.
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, visual, dimensional and functional testing could not be performed.In case of this complaint, the device was stated to have been in a good condition prior to the procedure and was prepared as per direction for use (dfu).Based on the available information and investigation results as assignable cause of undetermined was assigned to the as reported issue 'nv - stent partial deployment', as the device was not returned, and review and analysis of all available information failed to indicate as assignable cause.
Event or Problem Description
It was reported that during the procedure, the stent was partially deployed; however, the microcatheter slipped back to a position not suitable for implanting.The physician was able to pull back the microcatheter and partially deployed stent into the intermediate support microcatheter and both products were removed from the patient¿s body.Another stent was used to complete the procedure.There were no clinical consequences reported due to this event.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 21MM 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: 8087150
• Report Number: 3008881809-2018-00496
• Device Sequence Number: 19097199
• Product Code: NJE
• UDI-Device Identifier: 07613252656197
• UDI-Public: 07613252656197
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/03/2019

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: 05/20/2023
• Device Catalogue Number: M003SZAS40210
• Device Lot Number: 20563993
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1