MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 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 Codes	Stroke/CVA (1770); Hematoma (1884); Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that a patient underwent successful angioplasty and stenting with the subject stent of a high-grade left internal carotid artery (ica) ophthalmic segment intracranial stenosis with recurrent strokes.Apost-procedure the patient condition was stable.Three hours post-procedure, the patient developed stroke symptoms (expressive aphasia, rue (right upper extremity), rle (right lower extremity), weakness, right facial droop).Computed tomography (ct) head was done which demonstrated a large left frontal lobe intraparenchymal hemorrhage and a left front-temporal subarachnoid hemorrhage causing mass effect and a 5mm rightward midline shift.The patient received ddavp (desmopressin) and platelet transfusion, was brought to operating room, had decompressive craniectomy and decompression of the hematoma.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.There is no allegation of a device malfunction and the device remains implanted; therefore, visual, dimensional and functional testing was not performed.The reported events are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this investigation.
Event or Problem Description
It was reported that a patient underwent successful angioplasty and stenting with the subject stent of a high-grade left internal carotid artery (ica) ophthalmic segment intracranial stenosis with recurrent strokes.Apost-procedure the patient condition was stable.Three hours post-procedure, the patient developed stroke symptoms (expressive aphasia, rue (right upper extremity), rle (right lower extremity), weakness, right facial droop).Computed tomography (ct) head was done which demonstrated a large left frontal lobe intraparenchymal hemorrhage and a left front-temporal subarachnoid hemorrhage causing mass effect and a 5mm rightward midline shift.The patient received ddavp (desmopressin) and platelet transfusion, was brought to operating room, had decompressive craniectomy and decompression of the hematoma.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.5 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: 8502228
• Report Number: 3008881809-2019-00094
• Device Sequence Number: 19429107
• Product Code: NJE
• UDI-Device Identifier: 04546540722836
• UDI-Public: 04546540722836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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: 11/13/2021
• Device Catalogue Number: M003WS0350150
• Device Lot Number: 21032234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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: 40 YR
• Patient Weight: 92