• 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 DEMO SURPASS EVOLVE 4.5MM X 30MM - 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 DEMO SURPASS EVOLVE 4.5MM X 30MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number XFDS45030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
It was reported that the patient was involved in a car accident and had injuries due to car accident. The patient was having issues due to ccf (carotid-cavernous sinus fistula) prior to procedure that was being treated. The subject surpass evolve was implanted via trans femoral artery and several coils as well and 15 or so target coils were implanted via trans venous approach. The neurosurgery resident informed that the patient experienced subarachnoid hemorrhage (sah) and was brain dead the day after the procedure. On (b)(6) 2021, the patient was listed as brain dead and the patient had passed due to complication post-procedure. According to the physician, the cause of the sah and death were not determined. No one from the hospital including the physician have issued this as a product complaint. No other information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEMO SURPASS EVOLVE 4.5MM X 30MM - 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 Key12298498
MDR Text Key265810803
Report Number3008881809-2021-00329
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 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXFDS45030
Device Lot Number22413063
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 Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
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: 08/09/2021 Patient Sequence Number: 1
-
-