MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF F/G WINGSPAN STENT SYSTEM 3.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0350150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remained implanted.
Event or Problem Description
It was reported that post elective clipping of an anterior choroidal arterial aneurysm, the patient was treated for the left internal carotid artery (ica) stenosis (ophthalmic segment) by 4 balloon angioplasty.The second angioplasty with a non-stryker device was complicated with an endothelial dissection of the distal left ophthalmic segment of the ica.The stent (subject device) was uneventfully placed to treat the dissection and the stenosis at the stenotic segment.However, in-stent thrombosis with 2 foci of distal thromboembolism occurred.Platelet aggregation inhibitor (abciximab) was administered but in-stent thrombosis was persistent.Anticoagulant (heparin) was administered and in-stent thrombosis was improved.It was reported that in-stent thrombosis adverse event was resolved without clinical consequences.Post procedure, the patient had hemiparesis, which was believed most likely due to dissection.
Additional Manufacturer Narrative
The device history record (dhr) review confirms 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.However, patient thrombosis (treated vessel) is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.
Event or Problem Description
It was reported that post elective clipping of an anterior choroidal arterial aneurysm, the patient was treated for the left internal carotid artery (ica) stenosis (ophthalmic segment) by 4 balloon angioplasty.The second angioplasty with a non-stryker device was complicated with an endothelial dissection of the distal left ophthalmic segment of the ica.In the physician's opinion, the cause of the endothelial dissection flap was a combination of atherosclerotic disease involving the vessel wall, and the intraoperative manipulation of the ica that was necessary to visualize the branch vessels arising at the origin of the left anterior choroidal artery aneurysm.The stent (subject device) was uneventfully placed to treat the dissection and the stenosis at the stenotic segment.However, in-stent thrombosis with 2 foci of distal thromboembolism occurred.Platelet aggregation inhibitor (abciximab) was administered but in-stent thrombosis was persistent.Anticoagulant (heparin) was administered and in-stent thrombosis was improved.It was reported that in-stent thrombosis adverse event was resolved without clinical consequences.Post procedure, the patient had hemiparesis, which was believed most likely due to dissection.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.5 X 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 5964372
• Report Number: 3008881809-2016-00178
• Device Sequence Number: 13659736
• Product Code: NJE
• UDI-Device Identifier: 04546540722836
• UDI-Public: (01)04546540722836(17)181130(10)18692406
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

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 Expiration Date: 11/04/2018
• Device Catalogue Number: M003WS0350150
• Device Lot Number: 18692406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 11/09/2016
• 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; Required Intervention
• Patient Age: 62 YR