• 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 STREAMLINE 3.0MM X 25MM - IDE 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 STREAMLINE 3.0MM X 25MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003102USHP0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Fistula (1862); Neurological Deficit/Dysfunction (1982)
Event Date 09/29/2015
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
The start date for the event was (b)(6) 2015 (study day 0), with a resolution date of (b)(6) 2015. The event was reported as moderate in intensity, and probably related to the study device implant as well as the study device delivery system. The site reported that it was definitely related to the study procedure. There was high tortuosity of the patient¿s cavernous ica (internal carotid artery). A small cavernous carotid fistula was reported requiring temporary balloon occlusion of the left ica (internal carotid artery). The event was deemed serious as its prolonged hospitalization. The site further commented, ¿hospitalization was prolonged by complications of right sided weakness and difficulty speaking, suspicious for an acute stroke secondary to the procedure. Additional imaging was not completed at the time of the event to confirm stroke radiographically. Symptoms resolved independently over time. ¿ per last clinical encounter (b)(6) 2016 neurology, ¿the patient has done incredibly well and recovered beautifully from the small stroke that patient had. This may result in some of patient memory problems. They have been stable at this point. There is nothing on exam that is concerning for any kind of neurodegenerative process or any new strokes. ¿ per last phone encounter 14-august-2019 ¿patient and husband report decreasing memory over the last year but not significant enough to effect adls; patient feels that her stability has declined, and the patient has increasing difficulty with uneven surfaces and navigating around obstacles while walking, started around (b)(6) 2018¿.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS STREAMLINE 3.0MM X 25MM - IDE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10075489
MDR Text Key192249971
Report Number3008881809-2020-00151
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/09/2016
Device Catalogue NumberM003102USHP0
Device Lot Number18286480
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 Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2015
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: 05/20/2020 Patient Sequence Number: 1
-
-