MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3 X 9MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0300090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Intracranial Hemorrhage (1891)
Date of Event	06/16/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Subject device was implanted.
Event or Problem Description
It was reported that following angioplasty and stenting procedure for left middle cerebral artery (mca) stenosis, the patient's condition was stable and at neurological baseline.Approximately 18 hours post procedure, hemorrhage occurred in the left mca territory.Decompressive craniectomy was attempted by the physician to try to resolve the event.The event was not resolved and evaluated by physician to be a serious injury.Patient's condition worsened and patient expired 8 days after procedure.The physician considered the adverse event and subsequent death unrelated to the device.Other possible contributing factors to the event were hypertension.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.However, hemorrhagic event and death are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.Expiration date: added.Manufacturing date: added.
Event or Problem Description
It was reported that following angioplasty and stenting procedure for left middle cerebral artery (mca) stenosis, the patient's condition was stable and at neurological baseline.Approximately 18 hours post procedure, hemorrhage occurred in the left mca territory.Decompressive craniectomy was attempted by the physician to try to resolve the event.The event was not resolved and evaluated by physician to be a serious injury.Patient's condition worsened and patient expired 8 days after procedure.The physician considered the adverse event and subsequent death unrelated to the device.Other possible contributing factors to the event were hypertension.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3 X 9MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5765194
• Report Number: 3008881809-2016-00064
• Device Sequence Number: 3746
• Product Code: NJE
• UDI-Device Identifier: 04546540722799
• UDI-Public: (01)04546540722799(17)171130(10)18074490
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/17/2016

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: 11/30/2017
• Device Catalogue Number: M003WS0300090
• Device Lot Number: 18074490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 09/18/2016
• 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; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 74