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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Inflammation (1932)
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for analysis as they were implanted in the patients, therefore the event cause could not be determined. The causes of the post-procedure complications were not reported. Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event. Wfitn 2015 abstracts: poster display. (2015). Interventional neuroradiology, 21(1 suppl), 66-89. Doi:10. 1177/1591019915618081 mdrs related to this article: 2029214-2016-00538 2029214-2016-00539.
 
Event Description
Medtronic received information from literature review of patient complications after pipeline implantation. The purpose of this article was to review the clinical experience of the pipeline embolization device. Records of 16 patients (mean age 66 years) treated with pipeline were reviewed. The aneurysms were unruptured and ranged in size from 1. 5 to 3. 6cm. The aneurysms were located in the carotid cavernous, carotid ophthalmic, posterior communicating, and supraclinoid. It was reported that air embolism occurred in one patient without significant neurological sequelae. In addition, one patient experienced ophthalmoplegia secondary to petrositis.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
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
9496801224
MDR Report Key5781444
MDR Text Key49125408
Report Number2029214-2016-00539
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/13/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/10/2016 Patient Sequence Number: 1
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