MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003SFD040300

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

Patient Problems Stroke/CVA (1770); Seizures (2063); Thrombosis (2100); Visual Disturbances (2140); Vitreous Hemorrhage (2143)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

This is 2 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 ophthalmologic thromboembolic event (visual field compromise, ophthalmic artery thrombosis and retinal hemorrhage) were reported in 4 patients post procedure, this report addresses the complications.No further information is available.

Manufacturer Narrative

H6: patient codes: seizure, cerebrovascular accident.This is 2 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 ophthalmologic thromboembolic event (visual field compromise, ophthalmic artery thrombosis and retinal hemorrhage) were reported in 4 patients post procedure, this report addresses the complications.No further information is available.Additional information received on 7-may-2020: one patient was treated with a flow diverter (subject device) for bilobed right ophthalmic artery with dysplastic supraclinoid right internal carotid artery (ica) containing multiple blister aneurysms, 9.1 mm aneurysm with height of 1st lobe 8.62 mm and 2nd lobe 5.54 mm (stented with non-stryker stent) (aneurysm size 5-9.9 mm).The patient experienced left facial droop, generalized tonic-clonic seizure.Right ophthalmic artery thrombus was observed.There was cerebral infarction.The patient was treated with intraarterial intracatheter intracerebral integrilin 1 mg in right ica without improvement, repeat 1 mg resulting in delayed filling ophthalmic artery, another repeat 1 mg still without visualization of ophthalmic artery.Treated next with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 1 mg in right middle meningial artery resulting in complete reperfusion of right ophthalmic artery with choroidal blush.Right ophthalmic artery remaining patent on follow-up computed tomography angiography (cta) over next few days with demonstration of thrombosed aneurysm, complete resolution.Seizure localized to right hemisphere was observed.

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 with a flow diverter (subject device) for bilobed right ophthalmic artery with dysplastic supraclinoid right internal carotid artery (ica) containing multiple blister aneurysms, 9.1 mm aneurysm with height of 1st lobe 8.62 mm and 2nd lobe 5.54 mm (stented with non-stryker stent) (aneurysm size 5-9.9 mm).Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu/risk documents.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files., an assignable cause of anticipated procedural complication will be assigned to this complaint.

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 ophthalmologic thromboembolic event (visual field compromise, ophthalmic artery thrombosis and retinal hemorrhage) were reported in 4 patients post procedure, this report addresses the complications.No further information is available.Additional information received on 7-may-2020: one patient was treated with a flow diverter (subject device) for bilobed right ophthalmic artery with dysplastic supraclinoid right internal carotid artery (ica) containing multiple blister aneurysms, 9.1 mm aneurysm with height of 1st lobe 8.62 mm and 2nd lobe 5.54 mm (stented with non-stryker stent) (aneurysm size 5-9.9 mm).The patient experienced left facial droop, generalized tonic-clonic seizure.Right ophthalmic artery thrombus was observed.There was cerebral infarction.The patient was treated with intraarterial intracatheter intracerebral integrilin 1 mg in right ica without improvement, repeat 1 mg resulting in delayed filling ophthalmic artery, another repeat 1 mg still without visualization of ophthalmic artery.Treated next with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 1 mg in right middle meningial artery resulting in complete reperfusion of right ophthalmic artery with choroidal blush.Right ophthalmic artery remaining patent on follow-up computed tomography angiography (cta) over next few days with demonstration of thrombosed aneurysm, complete resolution.Seizure localized to right hemisphere was observed.

• Brand Name: SURPASS STREAMLINE 4.0MM X 30MM - 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: 9968080
• MDR Text Key: 187952580
• Report Number: 3008881809-2020-00106
• 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: 06/23/2020
• Device Catalogue Number: M003SFD040300
• Device Lot Number: 21551550
• 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: 52 YR