MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF F/G WINGSPAN STENT SYSTEM 3.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0350150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure at the basilar artery, the subject stent was unintentionally deployed prematurely inside the microcatheter ¾ of the way in and was left inside the microcatheter.A second stent was deployed successfully.There was no impact to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The stent was returned in the microcatheter.There was blood observed on the outer body catheter.Visual examination of the returned device revealed that the outer body was separated on its proximal/middle junction.The outer body was kinked 12.Cm from its proximal end.It was compressed at 51.0cm from its proximal.The inner body had been kinked 6.5cm from its proximal end.The inner body distal shaft had been separated on its middle/distal junction.The inner body distal shaft was not returned.During investigation, the stent was pushed out of the catheter.The stent was examined.And was found to be conforming to its visual specifications.The catheter (non-stryker device) was kinked on its shaft.Information from the complaint indicated that continuous flush was maintained and the patient's anatomy was minimally tortuous.There was no damage noted to the device prior to use and the stent delivery system was prepared as per the dfu.There was blood noted on the stent delivery system during analysis.The presence of blood is an indication that continuous flush was not maintained.The lack of continuous flush could have caused the reported and analyzed issues; however, information available indicated that continuous flush was maintained.Therefore a cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during procedure at the basilar artery, the subject stent was unintentionally deployed prematurely inside the microcatheter 3/4 of the way in and was left inside the microcatheter.A second stent was deployed successfully.There was no impact to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.5 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; model farm road; fremont CA 94538
• MDR Report Key: 5848386
• Report Number: 3008881809-2016-00113
• Device Sequence Number: 16342794
• Product Code: NJE
• UDI-Device Identifier: 04546540722836
• UDI-Public: (01)04546540722836(17)180831(10)18575501
• 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): 07/18/2016

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: 08/25/2018
• Device Catalogue Number: M003WS0350150
• Device Lot Number: 18575501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR