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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PIPELINE
Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Article website: http://jnis. Bmj. Com/content/early/2016/03/08/neurintsur g-2016-012261. Full there is limited information about the device and/or the patient, therefore all alleged product problems were captured in this report. Attempts were made to obtain additional information. A response was received stating that "there were no device related adverse events. As stated in the discussion section, the complication rate associated with pipeline classic correlates with aggressive operator manipulations. " no further information was provided. Same source article as reported in mdr mfr: 2029214-2016-00205, 2029214-2016-00206, 2029214-2016-00207.
 
Event Description
Medtronic received information through literature review that 17 pipeline classic deployment failure occurred in 57 consecutive patients who underwent treatment with the pipeline classic. The details of deployment failure were not provided. The authors also reported 7 patients required j-microwire and 6 patients required balloon angioplasty to fully open a deployed flow diverter. In cases of inadequate device apposition with the parent vessel wall after deployment, the operator typically attempted to facilitate opening of the flow diverter by navigating a microwire with a 'j' tip through the device. If the ped failed to open adequately with this technique, angioplasty of the stent was then attempted using a compliant balloon. In this article, the authors described their study to compare procedural outcomes between the first-generation device (pipeline classic) and the pipeline flex. Thirty-eight of the first 40 consecutive patients who underwent intracranial aneurysm treatment with the pipeline flex and 58 of the most recent 60 consecutive patients who underwent treatment with the pipeline classic at our institution were evaluated. Patient demographics, aneurysm characteristics, technical procedural details, and early outcomes were analyzed. The authors concluded that use of pipeline flex significantly reduces the total procedure and fluoroscopy time, contrast usage, patient radiation exposure, and proportion of recaptured devices in comparison with the pipeline classic, probably owing to an enhanced delivery system that allows for more reliable and controlled deployment. Citation: le ej, miller t, serulle y, et al. Use of pipeline flex is associated with reduced fluoroscopy time, procedure time, and technical failure compared with the first-generation pipeline embolization device. J neurointerv surg. 2016 mar 9. Pii: neurintsurg-2016-012261. Doi: 10. 1136/neurintsurg-2016-012261.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5553330
MDR Text Key105968739
Report Number2029214-2016-00204
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 03/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received03/11/2016
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

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