MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number UNK_NEU

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

Patient Problems Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Thromboembolism (2654)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Lot/serial no.: unknown.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 history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available the reported right sided weakness (neurological deficit), thrombosis and transient ischemic attack are known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported event.The device remains implanted in patient.

Event Description

It was reported that the patient suffered right sided weakness 3 weeks post the flow diverter (subject device) implantation at the left para-opthalmic internal carotid artery.On investigation, a thrombotic event was discovered at left para-opthalmic internal carotid artery which leading to the transient stroke symptoms.Intervention was required and the improvement was noticed after re-intervention.No further information is available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9608046
• MDR Text Key: 176099996
• Report Number: 3008881809-2020-00010
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR