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); Death (1802); Hyperglycemia (1905); Respiratory Distress (2045); Neurogenic Shock (2265)
Date of Event	06/25/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is the second of 2 reports.Subject device is not available.
Event or Problem Description
The patient was admitted for slurred speech and right-sided weakness, gait difficulty.Mri scan revealed subacute-looking left medial pontine infarct.The patient underwent angioplasty and then placement of a first stent system.Thereafter an overlapping 2nd stent (subject device) was placed.Post dilation was performed.Final projection demonstrated good stent apposition.No residual stenosis and excellent flow to distal vessels.After procedure, mri revealed left pons infarction.There was evidence of expanding pontine infarct over the time.Neurologically, on examination, it appeared that the patient had a locked -in syndrome and remained on mechanical ventilator.He continued a cardene drip.He could not be anticoagulated because of the brain injury.Ultimately, there was evidence of multiple embolic strokes involving the cerebellum and cerebrum.The patient developed cerebral edema and then brainstem herniation.Along with that.He developed hyperglycemia, acute respiratory distress syndrome (ards) and neurogenic shock.The patient died 5 days post procedure.The physician assessed that the adverse events were unlikely to be related to the subject device.The other possible contributing factor was co-morbidity.
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, adverse events associated with the use of coil or with the endovascular procedures include, but are not limited to: stroke, complications, and death are 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
The patient was admitted for slurred speech and right-sided weakness, gait difficulty.Mri scan revealed subacute-looking left medial pontine infarct.The patient underwent angioplasty and then placement of a first stent system.Thereafter an overlapping 2nd stent (subject device) was placed.Post dilation was performed.Final projection demonstrated good stent apposition.No residual stenosis and excellent flow to distal vessels.After procedure, mri revealed left pons infarction.There was evidence of expanding pontine infarct over the time.Neurologically, on examination, it appeared that the patient had a locked -in syndrome and remained on mechanical ventilator.He continued a cardene drip.He could not be anticoagulated because of the brain injury.Ultimately, there was evidence of multiple embolic strokes involving the cerebellum and cerebrum.The patient developed cerebral edema and then brainstem herniation.Along with that.He developed hyperglycemia, acute respiratory distress syndrome (ards) and neurogenic shock.The patient died 5 days post procedure.The physician assessed that the adverse events were unlikely to be related to the subject device.The other possible contributing factor was co-morbidity.

• 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: 7827854
• Report Number: 3008881809-2018-00368
• Device Sequence Number: 16465443
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: M003WS0350150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GATEWAY BALLOON CATHETER (STRYKER); WINGSPAN STENT SYSTEM (STRYKER)
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 56 YR