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

Model Number M003SFD040300

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

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

This is the 12th of 14 reports.Subject device remains implanted.

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.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with compression of optic chiasm, 19 x 16 mm (aneurysm size 5-20 mm) with very wide neck, & b/l vertebral dysplasia.Successful surpass assisted coiling embolization of large left ophthalmic aneurysm.The patient tolerated the procedure well and there were no angiographic complications from the procedure.However, after the patient was awakened from general anesthesia, expressive aphasia and right hemiparesis were noted.Head computerized tomography (ct) was performed which showed postoperative changes but no evidence of hemorrhage or infarct.Angiogram repeated and was negative for definitive clot, the patient was treated with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 2 mg and integrillin 2 mg in left internal carotid artery (ica) and kept on an integrilin drip in addition to aspirin and plavix.New 10 x 7 mm left retrolenticular/corona radiata acute infarct apparent on ct head following day.Major complication of stent thrombosis was established.Aphasia gradually improved some, persistent weakness/paresthesia.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.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with compression of optic chiasm, 19 x 16 mm (aneurysm size 5-20 mm) with very wide neck, & b/l vertebral dysplasia.Successful surpass assisted coiling embolization of large left ophthalmic aneurysm.The patient tolerated the procedure well and there were no angiographic complications from the procedure.However, after the patient was awakened from general anesthesia, expressive aphasia and right hemiparesis were noted.Head computerized tomography (ct) was performed which showed postoperative changes but no evidence of hemorrhage or infarct.Angiogram repeated and was negative for definitive clot, the patient was treated with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 2 mg and integrillin 2 mg in left internal carotid artery (ica) and kept on an integrilin drip in addition to aspirin and plavix.New 10 x 7 mm left retrolenticular/corona radiata acute infarct apparent on ct head following day.Major complication of stent thrombosis was established.Aphasia gradually improved some, persistent weakness/paresthesia.

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.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with compression of optic chiasm, 19 x 16 mm (aneurysm size 5-20 mm) with very wide neck, & b/l vertebral dysplasia.Successful surpass assisted coiling embolization of large left ophthalmic aneurysm.The patient tolerated the procedure well and there were no angiographic complications from the procedure.However, after the patient was awakened from general anesthesia, expressive aphasia and right hemiparesis were noted.Head computerized tomography (ct) was performed which showed postoperative changes but no evidence of hemorrhage or infarct.Angiogram repeated and was negative for definitive clot, the patient was treated with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 2 mg and integrillin 2 mg in left internal carotid artery (ica) and kept on an integrilin drip in addition to aspirin and plavix.New 10 x 7 mm left retrolenticular/corona radiata acute infarct apparent on ct head following day.Major complication of stent thrombosis was established.Aphasia gradually improved some, persistent weakness/paresthesia.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.One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with compression of optic chiasm, 19 x 16 mm (aneurysm size 5-20 mm) with very wide neck, & b/l vertebral dysplasia.Successful surpass assisted coiling embolization of large left ophthalmic aneurysm.The patient tolerated the procedure well and there were no angiographic complications from the procedure.However, after the patient was awakened from general anesthesia, expressive aphasia and right hemiparesis were noted.Head computerized tomography (ct) was performed which showed postoperative changes but no evidence of hemorrhage or infarct.Angiogram repeated and was negative for definitive clot, the patient was treated with intraarterial intracatheter intracerebral tissue plasminogen activator (tpa) 2 mg and integrillin 2 mg in left internal carotid artery (ica) and kept on an integrilin drip in addition to aspirin and plavix.New 10 x 7 mm left retrolenticular/corona radiata acute infarct apparent on ct head following day.Major complication of stent thrombosis was established.Aphasia gradually improved some, persistent weakness/paresthesia.

Manufacturer Narrative

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 implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with compression of optic chiasm, 19 x 16 mm (aneurysm size 5-20 mm) with very wide neck, & b/l vertebral dysplasia.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.

• 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: 10103947
• MDR Text Key: 193435967
• Report Number: 3008881809-2020-00161
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613252648796
• UDI-Public: 07613252648796
• 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
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: M003SFD040300
• Device Catalogue Number: M003SFD040300
• Device Lot Number: 21399280
• 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: 66 YR