MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Thrombosis (2100); Visual Disturbances (2140)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

This 3 of 8 reports.The device is not available to the manufacturer.

Event Description

It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients and stent thrombosis(ischemic thromboembolic event occurred required treatment with intraarterial intracatheter intracerebral integrilin and tpa(tissue plasminogen activator)) was reported on two patients, this report addresses the complications.No further information is available.

Manufacturer Narrative

Device code: corrected to activation failure including expansion failure.Patient code: added: visual disturbances.This 3 of 14 reports (corrected).

Event Description

It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients and stent thrombosis(ischemic thromboembolic event occurred required treatment with intraarterial intracatheter intracerebral integrilin and tpa(tissue plasminogen activator)) was reported on two patients, this report addresses the complications.No further information is available.Additional information received on 7-may-2020 regarding the 1st patient with stent thrombosis: one patient was treated with a flow diverter (subject device) for an unruptured aneurysm on the left ophthalmic artery with evidence of recent rupture, 8 x 7 mm (aneurysm size <4 mm to 9.9mm).Immediately after procedure, the patient was initially neurologically intact.Approximately 1 hour after procedure, the patient developed a left eye lateral inferior visual field defect.It was suspected that there was thrombosis of subject stent and distal thrombosis of left opthalmic artery.The patient was started on integrilin bolus/drip and was returned to angiography suite.The subject stent was patent and positioned well across neck of aneurysm, with significantly improved apposition of the subject stent along walls of left internal carotid artery (ica).However, there was incomplete apposition of the subject stent at the level of the opthalmic artery and the proximal cavernous ica.Sequentially, the stent was angioplastied distally to proximally.There was greater than 90% occlusion of the left opthalmic aneurysm with patent opthalmic artery.It was suspected that there was a minimal distal opthalmic artery thrombus.

Manufacturer Narrative

D4: expiration date: updated h4: manufacturing date: updated due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device dfu.As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.As per the surpass streamline dfu, intented use/indications for use: the surpass streamline flow diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width = 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter = 2.5 mm and = 5.3 mm.The available information indicates that the patient was treated for an unruptured aneurysm on the left ophthalmic artery with evidence of recent rupture, 8 x 7 mm (aneurysm size <4 mm to 9.9mm).Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu/risk documents.It cannot be definitively determined if the flow diverter failure to open caused or contributed to the patient harm, therefore an assignable cause of undeterminable will be assigned to the reported patient vessel thrombosis, patient neurological deficit.As the device was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported stent failed/unable to open, an assignable cause of undeterminable will be assigned.

Event Description

It was published in a literature abstract that cases performed between (b)(6) 2019 to (b)(6) 2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device).There were procedure related complications reported in 12 patients and stent thrombosis(ischemic thromboembolic event occurred required treatment with intraarterial intracatheter intracerebral integrilin and tpa(tissue plasminogen activator)) was reported on two patients, this report addresses the complications.No further information is available.Additional information received on 7-may-2020 regarding the 1st patient with stent thrombosis: one patient was treated with a flow diverter (subject device) for an unruptured aneurysm on the left ophthalmic artery with evidence of recent rupture, 8 x 7 mm (aneurysm size <4 mm to 9.9mm).Immediately after procedure, the patient was initially neurologically intact.Approximately 1 hour after procedure, the patient developed a left eye lateral inferior visual field defect.It was suspected that there was thrombosis of subject stent and distal thrombosis of left opthalmic artery.The patient was started on integrilin bolus/drip and was returned to angiography suite.The subject stent was patent and positioned well across neck of aneurysm, with significantly improved apposition of the subject stent along walls of left internal carotid artery (ica).However, there was incomplete apposition of the subject stent at the level of the opthalmic artery and the proximal cavernous ica.Sequentially, the stent was angioplastied distally to proximally.There was greater than 90% occlusion of the left opthalmic aneurysm with patent opthalmic artery.It was suspected that there was a minimal distal opthalmic artery thrombus.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9967990
• MDR Text Key: 187952464
• Report Number: 3008881809-2020-00107
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2019
• Device Catalogue Number: UNK_NEU
• Device Lot Number: 20953710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR