MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 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 Codes	Stroke/CVA (1770); Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	04/28/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is the first out of 2.The device remains implanted.
Event or Problem Description
Following balloon angioplasty, a stent (subject device) was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion.Approximately 6 hours post procedure, it was noted that the patient mental status changed.Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device remains implanted and is not available; therefore, functional testing as well as physical analysis cannot be performed.However, hemorrhage, stroke and death are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
Event or Problem Description
Following balloon angioplasty, a stent (subject device) was implanted to treat a 96% stenosed m1 middle cerebral artery (mca) lesion.Approximately 6 hours post procedure, it was noted that the patient mental status changed.Computed tomography (ct) scan confirmed that a massive cerebral hemorrhage resulted in a stroke with subsequent brain midline shift occurred, which led the following day to the patient's death.

• Brand Name: F/G WINGSPAN STENT SYSTEM 4.0 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5686969
• Report Number: 3008881809-2016-00011
• Device Sequence Number: 292254
• Product Code: NJE
• UDI-Device Identifier: 04546540722874
• UDI-Public: (01)04546540722874(17)180228(10)18258845
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2016

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: 02/28/2018
• Device Catalogue Number: M003WS0400200
• Device Lot Number: 18258845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2016
• Supplement Report FDA Received Date: 08/10/2016
• 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: Death; Other
• Patient Age: 67 YR