MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 3X20; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003101FPP0

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

Patient Problems Stroke/CVA (1770); Dysphasia (2195)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

This is report 1 of 2.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Stroke and patient complications (speech difficulties/ dysphasia) are known risks associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, anticipated in nature.Therefore, an assignable cause of anticipated procedural complications was assigned to this event.Subject device remains implanted.

Event Description

During the stenting procedure for one fusiform ica (internal carotid artery)-m1 mca (middle cerebral artery) aneurysm, it was reported that difficulty was encountered when unsheathing the stent.However, two stents were implanted successfully and post-procedure, modified rankin scale (mrs) was 3.Then the next day post procedure the patient had small embolic infarcts in the left anterior circulation hemisphere and mca territory infarction at insular cortex (l.Sin).In addition, ct (computed tomography), mra (magnetic resonance angiogram), and mri (magnetic resonance angiogram) on the same day showed infarct.Approximately 6 days post procedure, the patient was discharged from the intensive care and admitted to the neurology ward with continuing clopidogrel daily.According to the physician, the adverse event was related to the procedure and the implanted flow diverter.Six months post-procedure, the patient was still hospitalized and difficulties of speech has increased.No further information is available for now.

• Brand Name: SURPASS 3X20
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7916866
• MDR Text Key: 121992034
• Report Number: 3008881809-2018-00420
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 09/27/2018

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: 03/31/2020
• Device Catalogue Number: M003101FPP0
• Device Lot Number: 19678821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 83