MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number 121FPP

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

Patient Problems Stroke/CVA (1770); Stenosis (2263); Speech Disorder (4415); Embolism/Embolus (4438)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that left ica (internal carotid artery) c2 segment flow diverter implantation was performed in the patient with other relevant history of hyperlipidemia, osteoporosis. On the same day of procedure stenosis in subject flow diverter stent (stenosis rate: 1-25%) was noted. On the next day mri imaging was performed which revealed multiple micro embolism. The patient was reported to have stroke. According to the physician the stroke was non-serious but likely related to the procedure. Edaravone 30mg was administered twice a day for treatment of the stroke. On seventh of the procedure patient recovery was noted. Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule. Aspirin 100mg/day was giving to the patient from (b)(6) 2021, to now (ongoing). Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2021 to (b)(6) 2021. Now patient is taking clopidogrel 5omg/day from (b)(6) 2022 (ongoing). The procedure was completed successfully. No other information is available.

• Brand Name: SURPASS 5MM X 30MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14060374
• MDR Text Key: 290164692
• Report Number: 3008881809-2022-00164
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 121FPP
• Device Lot Number: 22359217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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 Treatment Data

Date Received: 04/08/2022 Patient Sequence Number: 1