MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN 4.5MM X 20MM - HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0450200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
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 the physician was advancing the subject wingspan stent system over the wire and he found the stabilizer of the stent was broken.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned.The reported lot number was confirmed from the returned packaging.On visual inspection, the proximal end of the stabilizer was kinked.Functional testing was not required as the defect was visually confirmed.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 it was noticed that the hypo tube was broken as he began to advance the entire system per the dfu, the guide catheter was flushed prior to insertion of the stent delivery system, continuous flush maintained and the anatomy was averagely tortuous.The device was returned and it was noted that the stabilizer was kinked rather than fractured, as was reported.It is probable that the kink was observed as a fractured, therefore the reported event was confirmed.An assignable cause of not confirmed will be assigned to the reported stent stabilizer broken/fractured during use, as it was noted not to be fractured.An assignable cause of procedural factors will be assigned to the analyzed stent stabilizer kinked/bent, the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure the physician was advancing the subject wingspan stent system over the wire and he found the stabilizer of the stent was broken.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: WINGSPAN 4.5MM X 20MM - HDE
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11304955
• Report Number: 3008881809-2021-00072
• Device Sequence Number: 2660751
• Product Code: NJE
• UDI-Device Identifier: 04546540722904
• UDI-Public: 04546540722904
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/27/2021

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: 07/06/2022
• Device Model Number: M003WS0450200
• Device Catalogue Number: M003WS0450200
• Device Lot Number: 21571106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1