• 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 5.0MM X 30MM - CE 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 5.0MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003121FPP0
Device Problem Difficult or Delayed Activation (2577)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure, the subject flow diverter was positioned for implantation and during release experienced resistance. Upon deployment, the subject flow diverter partially deployed, only 70% was released. It was unable to expand and settle in the patient¿s vessel wall. Physician tried to reposition and reopen the subject flow diverter but was unsuccessful. The subject flow diverter was completely removed from the patient anatomy, but the procedure was not successfully completed. A surgical delay of approximately one hour occurred during the procedure. No clinical consequences were reported to the patient due to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURPASS STREAMLINE 5.0MM X 30MM - CE
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 Key10131433
MDR Text Key194661004
Report Number3008881809-2020-00168
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberM003121FPP0
Device Lot Number19805153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-