MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0300150
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the stent was prematurely deployed.In addition, the stent delivery catheter outer body was deformed under the strain relief at 1cm from the hub, the outer shaft was kinked in numerous locations and the proximal end of the stent stabilizer inner body was broken/fractured.It is probable that the device was damaged during the clinical procedure and device performance was limited due to procedural factors during use; therefore, an assignable cause of operational context will be assigned to the observed anomaly.
Event or Problem Description
Analysis of the returned device revealed that the stent had prematurely deployed during use.No consequences to the patient were reported.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5848394
• Report Number: 3008881809-2016-00112
• Device Sequence Number: 733543
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: (01)04546540722805(17)180630(10)18451555
• 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
• Report Date (Section B): 12/18/2015

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: 06/30/2018
• Device Catalogue Number: M003WS0300150
• Device Lot Number: 18451555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1