• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD45012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Visual Disturbances (2140); Neck Pain (2433)
Event Date 10/15/2020
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported in the clinical trial, that following procedure in the left internal carotid artery-ophthalmic (c6 segment) with the subject flow diverter, the patient had white spots/floaters in the left eye 1 day post procedure and left sided headache and left sided intermittent neck 3 days post procedure. Imaging and ophthalmological review was done and no abnormalities were detected. The floaters were reported as recovering/resolving and the left sided headache and left sided intermittent neck have completely recovered/resolved. Both events are possibly related to the subject flow diverter. No treatment was required. No other information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS EVOLVE 4.5MM X 12MM - CE
Type of DeviceINTRACRANIAL 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 Key11882653
MDR Text Key252705483
Report Number3008881809-2021-00220
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/09/2021
Device Catalogue NumberFD45012
Device Lot Number22194400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2020
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: 05/26/2021 Patient Sequence Number: 1
Treatment
AXS CATALYST 5 (STRYKER); EXCELSIOR XT-27 CATHETER (STRYKER); STRYKER INFINITY LS 6F/90CM; STRYKER SYNCRO SOFT 0.014X 200CM
-
-