• 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 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 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-16
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. The report of migration after deployment event could not be confirmed, and the event cause could not be determined. It is possible that braid sizing may have contributed to the reported issue. Per our instructions for use (ifu): do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter. Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel. An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration. No lot history record review is required as there is no allegation or evidence of potential or confirmed manufacturing issues. All products are 100% inspected for damages and irregularities during manufacture.
 
Event Description
Medtronic received report that the flow diverter was alleged to have ¿shrunk¿. This event was reported to have required intervention. The patient was initial treated on (b)(6) 2016, as (b)(6) 2016, the patient was reported to have recover. Aneurysm was in the right internal carotid cavernous, unruptured, saccular, with max diameter 11. 3 mm, neck width 5. 4 mm. The aneurysm was found by mri taken due to dizziness.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key6587475
MDR Text Key106866929
Report Number2029214-2017-00698
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/02/2018
Device Model NumberPED-400-16
Device Lot NumberA083990
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 Received04/27/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/03/2015
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: 05/24/2017 Patient Sequence Number: 1
-
-