MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003UZAS30150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, while delivering the stent through the guide catheter, the subject stent was noted missing on the delivery wire and was not confirmed under fluoroscopy.The procedure was stopped and the physician will re-attempt to perform the procedure in two weeks.There was no clinical consequences to the patient and the patient was not affected as a result of the surgical delay or the due to the reported event.
Event or Problem Description
It was reported that during the procedure, while delivering the stent through the guide catheter, the subject stent was noted missing on the delivery wire and was not confirmed under fluoroscopy.The procedure was stopped and the physician will re-attempt to perform the procedure in two weeks.There was no clinical consequences to the patient and the patient was not affected as a result of the surgical delay or the due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for evaluation.Therefore, visual and functional analysis were not performed.The reported event is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.In the case of this complaint, it is likely that the stent was deployed prematurely during preparation/use and deployment was not noted until the device was being inserted in the guide catheter, this however cannot be conclusively determined.Additional information indicated that no damage was noted to the device/packaging before attempting to use the device.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of 'undeterminable' was assigned to the reported event.

• Brand Name: NEUROFORM ATLAS 3.0MM X 15MM NO TIP- PMA
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9918848
• Report Number: 3008881809-2020-00086
• Device Sequence Number: 19536650
• Product Code: NJE
• UDI-Device Identifier: 07613327382228
• UDI-Public: 07613327382228
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P180031
• 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): 04/13/2020

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: 05/14/2024
• Device Model Number: M003UZAS30150
• Device Catalogue Number: M003UZAS30150
• Device Lot Number: 21458712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1