MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 50MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003SFD040500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Occlusion (1984); Seizures, Focal (2260); Vascular Dissection (3160)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

This is 8 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 an event of proximal internal carotid artery dissection occurred due to technical difficult in deployment(subject device) that resulted in ischemic stroke, this report addresses the complications.No further information is available.

Manufacturer Narrative

This is 8 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 an event of proximal internal carotid artery dissection occurred due to technical difficult in deployment(subject device) that resulted in ischemic stroke, this report addresses the complications.No further information is available.Additional information received on 7-may-2020 regarding the 2nd patient it was reported that a patient underwent flow diverter stenting for a left middle cerebral artery (mca) distal m1 fusiform unruptured aneurysm with saccular component and dysplastic left mca, saccular component 22 x 13.4 x 12.8 mm (aneurysm size>20mm) with the flow diverter (subject device).There was technical difficulty in device deployment resulted in left internal carotid artery (ica) dissection at a 360 degree loop/kink causing left anterior choroidal artery occlusion, and l mca perforator occlusion.The patient was treated with integrilin 7 mg iv then 1 mg intraarterial intracatheter intracerebral & 5 mg tissue plasminogen activator (tpa) via left superficial temporal artery branches.Seizures.Patient outcome was that the intra-arterial ipsilateral and contralateral tpa as well as integrilin was given with recanalization of left anterior choroidal artery.The left lenticular striate arteries also demonstrated decreased perfusion.L mca infarct (left basal ganglia, left corona radiata, and distal left parietal) with right sided weakness and seizures (treated with ativan, keppra, vimpat) post embolization.On discharge to rehabilitation, the patient was nonverbal/aphasic, followed commands against gravity on the left side and has no movement on the right side.Complete resolution on periprocedural computed tomography angiography (cta).The patient experienced seizure with left temporal lobe focus.

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 underwent flow diverter stenting for a left middle cerebral artery (mca) distal m1 fusiform unruptured aneurysm with saccular component and dysplastic left mca, saccular component 22 x 13.4 x 12.8 mm (aneurysm size>20mm) with the flow diverter (subject device).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 device failure to deploy the stent caused or contributed to the patient harm, therefore an assignable cause of undeterminable will be assigned to the reported patient stroke, patient vessel dissection, patient neurological deficit and patient vessel occlusion.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 deploy, 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 an event of proximal internal carotid artery dissection occurred due to technical difficult in deployment(subject device) that resulted in ischemic stroke, this report addresses the complications.No further information is available.Additional information received on 7-may-2020 regarding the 2nd patient it was reported that a patient underwent flow diverter stenting for a left middle cerebral artery (mca) distal m1 fusiform unruptured aneurysm with saccular component and dysplastic left mca, saccular component 22 x 13.4 x 12.8 mm (aneurysm size>20mm) with the flow diverter (subject device).There was technical difficulty in device deployment resulted in left internal carotid artery (ica) dissection at a 360 degree loop/kink causing left anterior choroidal artery occlusion, and l mca perforator occlusion.The patient was treated with integrilin 7 mg iv then 1 mg intraarterial intracatheter intracerebral & 5 mg tissue plasminogen activator (tpa) via left superficial temporal artery branches.Seizures.Patient outcome was that the intra-arterial ipsilateral and contralateral tpa as well as integrilin was given with recanalization of left anterior choroidal artery.The left lenticular striate arteries also demonstrated decreased perfusion.L mca infarct (left basal ganglia, left corona radiata, and distal left parietal) with right sided weakness and seizures (treated with ativan, keppra, vimpat) post embolization.On discharge to rehabilitation, the patient was nonverbal/aphasic, followed commands against gravity on the left side and has no movement on the right side.Complete resolution on periprocedural computed tomography angiography (cta).The patient experienced seizure with left temporal lobe focus.

• Brand Name: SURPASS STREAMLINE 4.0MM X 50MM - PMA
• 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: 9968086
• MDR Text Key: 187953445
• Report Number: 3008881809-2020-00111
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: M003SFD040500
• Device Lot Number: 21785960
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR