• 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 17MM - 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 4.5MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS45017
Device Problem Activation Failure (3270)
Patient Problems Stroke/CVA (1770); Dysphasia (2195)
Event Date 05/18/2021
Event Type  Injury  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
A stent (subject device) was successfully deployed and implanted within the patient on (b)(6) 2021. Later the same evening, the patient was found to have stroke-like symptoms and presented with aphasia. The development of stroke-like symptoms and aphasia was reported to be related to the subject stent. A cta showed that the proximal end of the subject stent implant had partially closed off. It was reported that the proximal end of the subject stent likely was not fully opposed to the vessel wall which resulted in its gradual closing. After administering a medication (integrilin) the patient's symptoms had resolved and the patient was transported to the interventional lab for further evaluation. The subject stent was discovered on angiogram to have opened more than what was presented on the cta, but with a ledge still remaining. A new stent was placed within the proximal end of the subject stent to allow it to open. The remainder of the subject stent was fully intact and well opposed. Patients symptoms resolved after medication administration. No other clinical consequences were reported to the patient due to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS EVOLVE 4.5MM X 17MM - 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 Key11987694
MDR Text Key256252382
Report Number3008881809-2021-00246
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 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS45017
Device Catalogue NumberFDS45017
Device Lot Number22422917
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 Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
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: 06/11/2021 Patient Sequence Number: 1
-
-