• 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 12MM - PMAS 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 12MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS40012
Device Problem Activation Failure (3270)
Patient Problem Stenosis (2263)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that during a procedure in the left internal carotid artery, the proximal segment of the subject flow diverter was unable to open after deployment. Femoral access was used in moderately tortuous anatomy. The physician reported no resistance during delivery of the subject flow diverter. Any surgical delay that may have occurred during the procedure was unknown. A balloon was unable to be used to open the proximal segment of the subject flow diverter as access to the target location was lost. Sluggish flow was noted in the patients vessel due to proximal closing of the subject flow diverter. The physician administered anti coagulant medication to prevent/breakup any clot that may/might/or already formed as a result of the closed subject flow diverter. The patient was reported to have been taken to the intensive care unit. No other information is present.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS EVOLVE 4.0MM X 12MM - PMAS
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 Key12194214
MDR Text Key262410647
Report Number3008881809-2021-00304
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS40012
Device Catalogue NumberFDS40012
Device Lot Number22387941
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2020
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: 07/19/2021 Patient Sequence Number: 1
Treatment
EXCELSIOR XT-27 MICRO CATHETER (STRYKER)
-
-