• 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 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 4.0MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS40017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperplasia (1906); Stenosis (2263)
Event Date 11/11/2021
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that on the patient follow up, it was determined that the patient developed endoluminal intimal hyperplasia. The location of the implant was in the vasculature ica (internal carotid artery). Upon multi physician conference, it was suggested that the subject surpass evolve stent could be the cause. The patient¿s current condition is asymptomatic and there was not any mechanical injury to artery at the location of the hyperplasia via angiography. No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS EVOLVE 4.0MM 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 Key12977690
MDR Text Key282064448
Report Number3008881809-2021-00522
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 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS40017
Device Catalogue NumberFDS40017
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
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: 12/10/2021 Patient Sequence Number: 1
-
-