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

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

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL 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 Key: 5553330
• MDR Text Key: 42037717
• Report Number: 2029214-2016-00204
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: 03/11/2016
• Supplement Dates FDA Received: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00053 YR