• 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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Intracranial Hemorrhage (1891); Thrombosis (2100); Stenosis (2263)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
A lot history record review was not possible since the lot numbers were not reported. 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. International stroke conference oral abstracts - session title: aneurysm oral abstracts: abstract 8: the pipeline embolization device: midterm results and predictors of outcomes in 335 consecutive patients nohra chalouhi, badih daou, robert m starke, guilherme barros, stavropoula tjoumakaris, robert rosenwasser, david hasan, and pascal jabbour stroke. 2016;47:a8, mdrs related to this article: 2029214-2016-00449, 2029214-2016-00450.
 
Event Description
Medtronic received information from literature review that complications occurred after pipeline implantation. This study includes 335 patients who underwent pipeline treatment. The mean aneurysm size was 9. 4mm. Aneurysms were saccular (84%) and fusiform/dissection (16%). Mean number of pipelines used was 1. 2. Complications occurred in 5% of patients, which included hemorrhagic complications (3%) and thromboembolic complications (1. 5%). At the latest follow-up, favorable outcomes (mrs 0-2) were noted in 95. 7%. Neurologic mortality was 1. 7% and neurologic morbidity was 1. 2%.
 
Manufacturer Narrative
Additional information mdrs related to this article: 2029214-2016-00449 2029214-2016-00450 2029214-2017-00189.
 
Event Description
Medtronic received additional information from review of an article from the same institution and authors. The purpose of the article was to assess the safety and efficacy of the pipeline embolization device, to analyze the effect of operator experience on the complication rate, and to identify predictors of complications and obliteration. The article was a retrospective review of 120 aneurysms in 109 patients treated with the pipeline device. Of the patients, 89 were female and 20 were male; mean age was 57. 8 years. The article stated that symptomatic procedure-related complications included three cerebral hemorrhages, three thromboembolic events causing retinal infarcts, four thromboembolic events causing cerebral infarcts, and one carotid dissection. The article also stated that two patients had initially presented with symptoms of brainstem compression from basilar trunk aneurysms. After pipeline implantation, one patient remained severely disabled. Of the patients, 73 aneurysms were available for angiographic follow-up. Of the follow-ups, one patient had asymptomatic in-stent stenosis on follow-up angiography; stenosis was moderate and managed conservatively. Jabbour, p. Et al (2013). The pipeline embolization device. Neurosurgery, 73(1), 113-120. Doi:10. 1227/01. Neu. 0000429844. 06955. 39.
 
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)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key5752028
MDR Text Key48256814
Report Number2029214-2016-00449
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
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 Received02/22/2017
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: 06/27/2016 Patient Sequence Number: 1
-
-