MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3 X 9MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0300090
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician experienced resistance during stent (subject device) deployment during the procedure and upon removal, the stent detached prematurely inside the guide catheter.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.Visual and microscopic inspection of the device found that there was procedural fluid was noted within the delivery catheter and the stabilizer.The stent was not returned with the device as it had been deployed during use, confirming the reported event of premature deployment during use.The delivery catheter was noted to be deformed at 11cm from the proximal end.The distal 40cm section of the delivery catheter was noted to be flattened as well.During functional evaluation, delivery catheter was flushed without difficulty and high friction was felt during an attempt to advance/ retract the stabilizer.The stabilizer was unable to be moved.Information from the complaint indicated that the target area was noted to be tortuous and there was focal stenosis at the lesion, which may contributed to the damages on the device.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 component failure has been assigned to this investigation.
Event or Problem Description
It was reported that the physician experienced resistance during stent (subject device) deployment during the procedure and upon removal, the stent detached prematurely inside the guide catheter.There were no reported clinical consequences to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3 X 9MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8158539
• Report Number: 3008881809-2018-00527
• Device Sequence Number: 16210308
• Product Code: NJE
• UDI-Device Identifier: 04546540722799
• UDI-Public: 04546540722799
• 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): 02/11/2019

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: 08/21/2021
• Device Catalogue Number: M003WS0300090
• Device Lot Number: 20831995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/11/2019
• 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: AXS INFINITY GUIDE CATHETER(STRYKER)
• Patient Age: 73 YR