• 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 5 X 50 SURPASSTM SYSTEM 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 5 X 50 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 123FPP
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned.
 
Event Description
It was reported that during the procedure, the subject stent was partially deployed when advanced through the catheter. No patient consequences were reported due to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name5 X 50 SURPASSTM SYSTEM
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8782609
MDR Text Key150767770
Report Number3008881809-2019-00198
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number123FPP
Device Lot Number19985548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-