MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

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

Patient Problem Stenosis (2263)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.The device remains implanted in the patient.

Event Description

It was reported that a patient had their para ophthalmic aneurysm treated with the stent flow diverter (subject device) on (b)(6) 2019 and approximately two weeks later, the patient was presented with a minor narrowing(40 -50%) of their supraclinoid ica just distal to the distal edge of the stent flow diverter.The cause of the narrowing of the vessel was not confirmed and may or may not be attributed to the implant.A secondary procedure was performed to extend the stent distally with another stent (non-stryker stent) and post angioplasty.The angiographic result showed that the narrowing had been fixed, and the patient has recovered well.The patient was reported to be in good condition.No further information is available.

Manufacturer Narrative

B5: updated to reflect received from hospital on (b)(6) 2020.Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis and remains implanted in the patient; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.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.As per the product dfu, experience with endovascular implants indicates that there is a risk of stenosis.Subsequent stenosis may require dilatation of the vessel segment containing the device.Based on additional information received, the reported event has been assessed as parent vessel stenosis instead of re-stenosis of the treated vessel.However, vessel dissection is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, an assignable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that a patient had their para ophthalmic aneurysm treated with the stent flow diverter (subject device) on 26-nov-2019 and approximately two weeks later, the patient was presented with a minor narrowing(40 -50%) of their supraclinoid ica just distal to the distal edge of the stent flow diverter.The cause of the narrowing of the vessel was not confirmed and may or may not be attributed to the implant.A secondary procedure was performed to extend the stent distally with another stent (non-stryker stent) and post angioplasty.The angiographic result showed that the narrowing had been fixed, and the patient has recovered well.The patient was reported to be in good condition.No further information is available.It was additionally confirmed on 25-feb-2020 with the hospital that the reported 40-50% narrowing (parent vessel stenosis) reported occurred two weeks post-procedure.There was no device malfunction during the procedure as well.No further information available at this time.

• Brand Name: UNKNOWN (SURPASS STREAMLINE)
• 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: 9533596
• MDR Text Key: 176098997
• Report Number: 3008881809-2019-00415
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_NEU
• Device Lot Number: 21570416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention