MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 4.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0450200
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to the manufacturer.
Event or Problem Description
It was reported that during treatment a basilar artery stenosis with a balloon and the subject device stent system, the subject device stent was successfully deployed and expanded, but upon retrieval of its delivery system, something must have grabbed the proximal portion of the deployed stent.When the subject device stent system catheters were removed, the system "jumped" (i.E.Released energy), and upon removal from the body, showed that part of the subject device stent had broken in half and was removed from the body with the catheter system.The rest of the subject device stent remained implanted in the patient's basilar artery.In order to ensure the subject device stent was opposing the walls within the patient's basilar artery, the physician then tracked a microcatheter through the lumen of the stent in the basilar and proceeded to deploy two another stents inside the patient's basilar artery.The patient's angiographic results looked satisfactory post-deployment, and the patient showed no adverse clinical events from the procedure.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The analysed 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 analysed event.As the device was not returned and review and analysis of all available information fail to indicate an assignable cause or probable assignable cause for the reported event, therefore; an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during treatment a basilar artery stenosis with a balloon and the subject device stent system, the subject device stent was successfully deployed and expanded, but upon retrieval of its delivery system, something must have grabbed the proximal portion of the deployed stent.When the subject device stent system catheters were removed, the system "jumped" (i.E.Released energy), and upon removal from the body, showed that part of the subject device stent had broken in half and was removed from the body with the catheter system.The rest of the subject device stent remained implanted in the patient's basilar artery.In order to ensure the subject device stent was opposing the walls within the patient's basilar artery, the physician then tracked a microcatheter through the lumen of the stent in the basilar and proceeded to deploy two another stents inside the patient's basilar artery.The patient's angiographic results looked satisfactory post-deployment, and the patient showed no adverse clinical events from the procedure.

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.5 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8466955
• Report Number: 3008881809-2019-00084
• Device Sequence Number: 10811133
• Product Code: NJE
• UDI-Device Identifier: 04546540722904
• UDI-Public: 04546540722904
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: M003WS0450200
• Device Lot Number: 19805615
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT-27 MICROCATHETER (STRYKER).; GATEWAY BALLOON CATHETER (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention