MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF F/G WINGSPAN STENT SYSTEM 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0400200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
The patient underwent uneventful stenting of the petrous segment located in the left internal carotid artery.It was reported that four days post procedure, the patient developed transient ischemic attack (tia).No treatment was required and the event resolved without any residual effects.The patient was discharged approximately three days later assessed having an mrs of 1.Relationship of the device performance to the tia was reported as unknown.The patient's current condition was reported as "pretty good".
Additional Manufacturer Narrative
Based on the additional information received from the facility, it is confirmed that the index procedure was completed successfully.In physician¿s opinion all of the devices performed as intended and there was no allegation against any of the devices.In physician¿s opinion, the outcome of the reported transient ischemic attack (tia) was due to patient¿ not adhering to the prescribed medication regimen for anti-platelet therapy.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
The patient underwent uneventful stenting of the petrous segment located in the left internal carotid artery.It was reported that four days post procedure, the patient developed transient ischemic attack (tia).No treatment was required and the event resolved without any residual effects.The patient was discharged approximately three days later assessed having an mrs of 1.Relationship of the device performance to the tia was reported as unknown.The patient's current condition was reported as "pretty good".

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.0 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 6631047
• Report Number: 3008853977-2017-00002
• Device Sequence Number: 13779361
• Product Code: NJE
• UDI-Device Identifier: 04546540722874
• UDI-Public: (01)04546540722874(17)190930(10)19349569
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M003WS0400200
• Device Lot Number: 19349569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR