MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SZAS40240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884); Pneumonia (2011); Multiple Organ Dysfunction Syndrome (3261)
Date of Event	07/24/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is the first of 2 reports.Subject device remains implanted.
Event or Problem Description
It was reported that 2 month-post successful stent-assisted coil embolization of an aneurysm located on the basilar apex, the patient mechanically fell and had subsequent falcine subdural hematoma.Hospitalization/prolonged hospitalization was required.The event was resolved without residual effects 2 days later.Eight days post fall, the patient suffered severe aspiration pneumonia and multi organ system failure.The patient died 15 days post fall.According to the clinical events committee (cec), the fall and subsequent falcine subdural hematoma were related to parkinson's disease, concomitant medication (plavix/asa), and atlas stents (subject device) and severe aspiration pneumonia and multi organ system failure were related to parkinson's disease, medical complications, and atlas stents.Had the patient not had an intracranial stent, she would not have been on dual antiplatelet therapy (dapt), so this event is device and drug related.
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.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 stent or with the endovascular procedures include, but are not limited to: complications, death and 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 2 month-post successful stent-assisted coil embolization of an aneurysm located on the basilar apex, the patient mechanically fell and had subsequent falcine subdural hematoma.Hospitalization/prolonged hospitalization was required.The event was resolved without residual effects 2 days later.Eight days post fall, the patient suffered severe aspiration pneumonia and multi organ system failure.The patient died 15 days post fall.According to the clinical events committee (cec), the fall and subsequent falcine subdural hematoma were related to parkinson's disease, concomitant medication (plavix/asa), and atlas stents (subject device) and severe aspiration pneumonia and multi organ system failure were related to parkinson's disease, medical complications, and atlas stents.Had the patient not had an intracranial stent, she would not have been on dual antiplatelet therapy (dapt) so this event is device and drug related.

• Brand Name: NEUROFORM ATLAS STENT SYSTEM 4.0 X 24MM WITHOUT TIP
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7704724
• Report Number: 3008881809-2018-00315
• Device Sequence Number: 1018656
• Product Code: NJE
• UDI-Device Identifier: 07613252656203
• UDI-Public: 07613252656203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: H020002/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: M003SZAS40240
• Device Lot Number: 19178493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: 75 YR