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

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2011

Event Type  Injury  

Event Description

Information received from the article: faria et al.The role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms.Am j neuroradiol 32:2192-95 dec 2011.Medtronic (covidien) received information through literature review and the following event(s) were captured as a result of the review; 23 patients (mean age 50, 12 females) were treated with pipeline devices.Five devices were not successfully deployed on the first attempt.One of these devices fell into the aneurysm sac, two devices slipped proximally during deployment, and the last two foreshortened and compacted making them miss total neck coverage which required deployment of an additional pipeline.No further information was available.Information received from the same article as mdr# 2029214-2015-00274.

Manufacturer Narrative

The report was created to capture the device complications.The information was received from the article: information received from the article: faria et al.The role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms.Am j neuroradiol 32:2192-95 dec 2011.Http://dx.Doi.Org/10.3174/ajnr.A2671.The lot history record review was not possible as the lot number was not reported.The devices will not be returned for evaluation as they were implanted in the patient.(b)(4).

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL 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 Key: 4621594
• MDR Text Key: 5594635
• Report Number: 2029214-2015-00273
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/20/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR