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

Model Number	M003WS0300150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner body tip on the stent stabilizer system separated upon withdrawal of system after stent deployment.There were no reported clinical consequences 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 not returned as it had been implanted.Visual and microscopic inspection of the device found that the distal 4cm stent stabilizer was returned detached from the device.The delivery catheter was kinked at 16cm from the distal end and the distal tip/ radio opaque (ro) marker of the delivery catheter was noted to be flattened.No other anomalies were noted.During functional testing, the stabilizer and the delivery catheter were flushed without difficulty and resistance was experienced as the stabilizer was advanced and retracted through the delivery catheter.During the patency test, resistance was experienced at the distal tip of the delivery catheter.Information available indicated that the device was confirmed to be in good condition prior to use and the device was prepared as per the dfu.Based on the information provided and investigation results, it is possible that the device was damaged during removal from the patient during use.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the stent during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
It was reported that the inner body tip on the stent stabilizer system separated upon withdrawal of system after stent deployment.There were no reported clinical consequences to the patient.

• 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: 6942624
• Report Number: 3008881809-2017-00439
• Device Sequence Number: 705384
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: (01)04546540722805(17)180731(10)18527740
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 12/21/2017

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: 07/31/2018
• Device Model Number: M003WS0300150
• Device Catalogue Number: M003WS0300150
• Device Lot Number: 18527740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1