MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS40240
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device implanted.
Event or Problem Description
It was reported that during the procedure, the stent was deployed from the right posterior cerebral artery (pca) to the basilar artery (ba).The stent opened proximally in the basilar artery; however, the distal of the stent did not open in the posterior cerebral artery.There were no clinical consequences to the patient reported.
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, dimension and functional testing could not be performed.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, dimension and functional testing could not be performed.As per the additional information provided in the complaint, the device was inspected and confirmed to be in a good condition during/after unpacking and preparation, and the device was prepared as per direction for use (dfu).In case of this complaint, there are several potential causes for the reported issue, but because review of available information failed to identify a definitive cause and since the product was not returned for analysis, a cause of undetermined was assigned to the as reported issue 'nv ¿ stent failed/unable to open'.
Event or Problem Description
It was reported that during the procedure, the stent was deployed from the right posterior cerebral artery (pca) to the basilar artery (ba).The stent opened proximally in the basilar artery; however, the distal of the stent did not open in the posterior cerebral artery.There were no clinical consequences to the patient reported.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 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: 7860479
• Report Number: 3008881809-2018-00394
• Device Sequence Number: 1337366
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Expiration Date: 03/07/2023
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 20381712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1