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 Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not available.
Event or Problem Description
It was reported the stent (subject device) prematurely deployed inside the patient.There was no was no clinical consequence reported due to this event.
Event or Problem Description
It was reported the stent (subject device) prematurely deployedinside the patient.There was no was no clinical consequence reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).The risk of the reported event has been addressed in the risk documentation and there are current controls in place to mitigate the risk of the as reported event.Based on the information currently available, it is probable the tortuosity of the patients anatomy may have caused difficulties during the procedure, therefore an assignable cause of procedural factors will be assigned to the investigation.

• 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: 8890714
• Report Number: 3008881809-2019-00240
• Device Sequence Number: 233638
• Product Code: NJE
• UDI-Device Identifier: 04546540722805
• UDI-Public: 04546540722805
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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 Catalogue Number: M003WS0300150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1