• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY 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
 

COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-18
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the endovascular device failed to open and was removed from the patient.
 
Manufacturer Narrative
The device was not returned as it was implanted in the patient. Follow up attempts have been, however, our attempts have been unsuccessful. Since the device was not returned, we are unable to perform further root cause analysis. Per our instructions for use (ifu): begin to deliver the device using a combination of unsheathing the embolization device and pushing delivery wire simultaneously. After the distal end of the embolization device has successfully expanded, deploy the remainder of embolization device by pushing the delivery wire and/or unsheathing the embolization device. Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the embolization device. It is not recommended to initiate deployment of the device on a bend. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or steno sis. All products are 100% inspected for damages and irregularities during manufacture.
 
Event Description
Medtronic received report that a competitor balloon was used to open the a section of the device. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7061301
MDR Text Key248794480
Report Number2029214-2017-01307
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/15/2019
Device Model NumberPED2-450-18
Device Lot NumberA327838
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/15/2016
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: 11/27/2017 Patient Sequence Number: 1
-
-