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 Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch mw5076912.Subject device remains implanted.
Event or Problem Description
Medwatch report (mw5076912) was received from the fda on may 21, 2018.It was reported that the patient went under general anesthesia for angioplasty procedure to treat stenosis at left internal carotid artery (lica).During procedure, the physician tried to exchange the balloon catheter with the subject stent deliver system.During the exchange, the customer notice that the subject stent became un-sheathed and was not able to pull the stent back into the sheath.The physician decided to deploy the subject stent in the distal vertical segment of the petrous to avoid damaging the vessel.The delivery system was then exchange and new stent was deployed successfully in the horizontal petrous segment to complete the procedure.The post-surgical angiogram showed less than 50% residual.No thrombus or dissection were observed.There were no reported clinical patient complications due to this event.No other information was provided.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.As per the event description, the physician attempted to re-sheath the stent into the catheter after the stent had begun to deploy against the direction for use (dfu).The wingspan stent dfu states that ¿do not attempt to move the stent after deployment has begun.Be careful to not advance the delivery system outer body as the stent is deploying.¿; therefore, an assignable cause of user error was assigned to the as reported ¿nv-stent difficult/unable to pull back into the sheath', as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.Since no additional information was received and the device was not returned for evaluation; therefore, an assignable cause of undeterminable was assigned to the as reported ¿nv-stent deployed prematurely during use'.
Event or Problem Description
Medwatch report (mw5076912) was received from the fda on may 21, 2018.It was reported that the patient went under general anesthesia for angioplasty procedure to treat stenosis at left internal carotid artery (lica).During procedure, the physician tried to exchange the balloon catheter with the subject stent deliver system.During the exchange, the customer notice that the subject stent became un-sheathed and was not able to pull the stent back into the sheath.The physician decided to deploy the subject stent in the distal vertical segment of the petrous to avoid damaging the vessel.The delivery system was then exchange and new stent was deployed successfully in the horizontal petrous segment to complete the procedure.The post-surgical angiogram showed less than 50% residual.No thrombus or dissection were observed.There were no reported clinical patient complications due to this event.No other information was provided.

• 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: 7576418
• Report Number: 3008881809-2018-00256
• Device Sequence Number: 1754610
• Product Code: NJE
• UDI-Device Identifier: 04546540722904
• UDI-Public: 04546540722904
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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: 07/31/2019
• Device Catalogue Number: M003WS0450200
• Device Lot Number: 19190474
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: Required Intervention