MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK WINGSPAN STENT SYSTEM 3.0MM X 20MM - HDE; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0300200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure the subject stent was deployed at the basilar artery.Physician noted that vessel perforation had occurred.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information provided.
Event or Problem Description
It was reported that during the procedure the subject stent was deployed at the basilar artery.Physician noted that vessel perforation had occurred.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information provided.
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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.While the reported events is also documented in the wingspan dfu as observed/ anticipated adverse events, the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use.As per the additional information, the patient was very sick with basilar artery disease.The anatomy was tortuous.It is most probable that there were some procedural or anatomical factors present during the clinical procedure which contributed to the patient vessel perforation.An probable assignable cause of procedural factors will be assigned to the reported patient harm, as 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.

• Brand Name: WINGSPAN STENT SYSTEM 3.0MM 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: 10554357
• Report Number: 3008881809-2020-00270
• Device Sequence Number: 3539037
• Product Code: NJE
• UDI-Device Identifier: 04546540722812
• UDI-Public: 04546540722812
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: M003WS0300200
• Device Catalogue Number: M003WS0300200
• Device Lot Number: 21415414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other