Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 4.0MM X 20MM - 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 4.0MM X 20MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40020
Device Problem Activation Failure (3270)
Patient Problem Stenosis (2263)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in patient.
 
Event Description
It was reported that the patient's anatomy showed fish mouth effect and a decrease of the caliber of the artery in the distal end due to implantation of stent (subject device) 9 months post procedure.Another device was used as a medical intervention since the proximal end was not well opposed against the vessel walls.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Event Description
It was reported that the patient's anatomy showed fish mouth effect and a decrease of the caliber of the artery in the distal end due to implantation of stent (subject device) 9 months post procedure.Another device was used as a medical intervention since the proximal end was not well opposed against the vessel walls.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.Update : an additional information was received on 12/30/2020 indicating that the subject stent was left inside the left internal carotid artery (ica) and the patient did not suffer any neurological deficits.The patient is table and asymptomatic.The physician is planning to do another follow up next march and no further surgery planned so far.
 
Manufacturer Narrative
B5 executive summary - updated.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, 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.It was reported that fish mouthing and a decrease in caliber of the artery at the distal end of the implanted flow diverter stent was noted during 9 month follow up post procedure.Additional information provided by the customer indicated that the subject device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was not tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURPASS EVOLVE 4.0MM X 20MM - CE
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11167793
MDR Text Key227579484
Report Number3008881809-2021-00026
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2020
Device Catalogue NumberFD40020
Device Lot Number21990250
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AXS CATALYST 5 CATHETER (STRYKER); AXS INFINITY LS CATHETER (STRYKER); EXCELSIOR XT-27 CATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER)
Patient Outcome(s) Other; Required Intervention;
-
-