MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 25MM - PMA; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003SFD040250

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

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 02/13/2019

Event Type  Death  

Manufacturer Narrative

This is 1 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 death was reported on two patients, this report addresses the mortality event relating to the first patient.No further information is available.

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 death was reported on two patients, this report addresses the mortality event relating to the first patient.No further information is available.Additional information received 7-may-2020 regarding the 1st patient: the patient was treated with the flow diverter (subject device) for an aneurysm located on the left internal carotid artery petro-cavernous eroded bony canal with intradural compartment, 8 x 7 x 5 mm (aneurysm size 5 to 9.9 mm).There was technical difficulty in device deployment resulted in suspected distal mca guidewire (unknown manufacturer) perforation as a cause of immediate post-procedural subarachnoid hemorrhage (sah).The sah occurred within 24 hours of procedure, presumed to be 2/2 anticoagulation following repeat angiogram.The patient was treated with left internal carotid artery (ica) occlusion.Outcome of the patient was, post-angiography, expressive aphasia; head computed tomography (ct) showed left temporal sah.Progressed to left facial droop, worsening dysarthria, and right hemiplegia.Intubated for altered mental status (ams) and airway protection.Supra-selective angiography of the left m1 segment, left m2 anterior division and left m2 posterior division shows no evidence of vascular injury within the left middle cerebral artery (mca).Therefore, the presumed cause of delayed left sylvian fissure hemorrhage after embolization was likely anticoagulation.Subsequently developed malignant cerebral edema requiring take down of surpass device and reversal of anticoagulation prior to left hemi-craniotomy.Aphasic, hemiplegic, tracheostomy and percutaneous endoscopic gastrostomy (peg), hydrocephalus 2 months out.Death occurred on (b)(6) 2019.

Manufacturer Narrative

A2: age: updated.A3: gender: updated.B2: executive summary: updated.B2: death date: added.B2: death date: updated.B3: event date: updated.D1: product long description: updated.D4: lot#: updated.D6: date of implant: updated.D11: concomitant device: added guidewire (unknown manufacturer).H6: patient codes: perforation, vessel of and intracranial hemorrhage added.This is 1st of 14 reports (corrected).

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 aneurysm was in the left internal carotid artery petro cavernous eroded bony canal w/i intradural compartment, 8 x 7 x 5 mm (aneurysm size <5mm-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 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 death, patient vessel perforation and patient intracranial hemorrhage.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 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 death was reported on two patients, this report addresses the mortality event relating to the first patient.No further information is available.Additional information received 7-may-2020 regarding the 1st patient: the patient was treated with the flow diverter (subject device) for an aneurysm located on the left internal carotid artery petro-cavernous eroded bony canal with intradural compartment, 8 x 7 x 5 mm (aneurysm size <5 to 9.9 mm).There was technical difficulty in device deployment resulted in suspected distal mca guidewire (unknown manufacturer) perforation as a cause of immediate post-procedural subarachnoid hemorrhage (sah).The sah occurred within 24 hours of procedure, presumed to be 2/2 anticoagulation following repeat angiogram.The patient was treated with left internal carotid artery (ica) occlusion.Outcome of the patient was, post-angiography, expressive aphasia; head computed tomography (ct) showed left temporal sah.Progressed to left facial droop, worsening dysarthria, and right hemiplegia.Intubated for altered mental status (ams) and airway protection.Supra-selective angiography of the left m1 segment, left m2 anterior division and left m2 posterior division shows no evidence of vascular injury within the left middle cerebral artery (mca).Therefore, the presumed cause of delayed left sylvian fissure hemorrhage after embolization was likely anticoagulation.Subsequently developed malignant cerebral edema requiring take down of surpass device and reversal of anticoagulation prior to left hemi-craniotomy.Aphasic, hemiplegic, tracheostomy and percutaneous endoscopic gastrostomy (peg), hydrocephalus 2 months out.Death occurred on (b)(6) 2019.

• Brand Name: SURPASS STREAMLINE 4.0MM X 25MM - 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: 9967991
• MDR Text Key: 187904579
• Report Number: 3008881809-2020-00105
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2019
• Device Catalogue Number: M003SFD040250
• Device Lot Number: 21049977
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/07/2020; 07/07/2020
• Supplement Dates FDA Received: 05/29/2020; 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Death
• Patient Age: 68 YR