MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.0MM X 15MM - HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0300150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure pusher wire of the stent delivery system (subject device) may have broken or bent inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported event cannot be confirmed, and it cannot be confirmed if the device met specification, as the device was not analyzed.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, 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.As per the additional information, the subject stent system was advanced inside a microcatheter, as per the stent dfu, the wingspan system is indicated for use with a balloon catheter.It is probable that was damaged during navigation and during the deployment attempt within the microcatheter, as this is an incompatible device.An assignable cause of user error will be assigned to this complaint, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the procedure pusher wire of the stent delivery system (subject device) may have broken or bent inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN STENT SYSTEM 3.0MM X 15MM - HDE
• 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: 9899220
• Report Number: 3008881809-2020-00080
• Device Sequence Number: 2807943
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: 04546540722805
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• 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): 05/18/2020

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: 03/03/2022
• Device Model Number: M003WS0300150
• Device Catalogue Number: M003WS0300150
• Device Lot Number: 21282882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1