• 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 EMBOLIZATION DEVICE 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 EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PIPELINE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Aneurysm (1708)
Event Date 12/19/2013
Event Type  Injury  
Manufacturer Narrative

Article website: http://www. Ajnr. Org/content/35/5/948. Long. The lot history record review was not possible since the lot numbers were not reported. The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined. Another serious adverse event from the same article was reported in mdr# 2029214-2015-00913.

 
Event Description

Medtronic (covidien) received information that one patient experienced a slight upgaze limitation post pipeline embolization device (ped) treatment. The patient presented with visual obscurations and was found to have giant cavernous sinus aneurysm. The patient was treated with 2 peds. Immediately after the procedure, the patient had a delayed, complete cavernous sinus syndrome. At six month follow up the patient had almost complete resolution of these new symptoms but continues to have slight upgaze limitation. In this article, the authors reported rates of occlusion and treatment-related data in 44 patients with cavernous sinus aneurysms treated with flow diversion (ped and other flow diversion devices). Citation: r. C. Puffera, m. Pianoc, g. Lanzino, et al. Treatment of cavernous sinus aneurysms with flow diversion: results in 44 patients. Ajnr am j neuroradiol. 2014 may;35(5):948-51. Doi: (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine 
9498373700
MDR Report Key5026121
MDR Text Key23908918
Report Number2029214-2015-00913
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPIPELINE
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 Received08/04/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/24/2015 Patient Sequence Number: 1
-
-