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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

Off-label use: the reported pipeline embolization device (ped) was used to treat a cervical carotid aneurysm (extracranial carotid artery aneurysm).According to the ped instruction for use (ifu) the ped is indicated for the endovascular treatment of adults ((b)(6) years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.The device model and lot numbers were not reported.The device will not be returned for evaluation as it remains in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause was unknown.

Event Description

The following report was received by medtronic: a patient developed a retrograde endoleak approximately two years post pipeline treatment.The aneurysm was saccular unruptured located in the right cervical.It was found that the pipeline classic was not apposed distally.The endoleak was confirmed on the date of re-treatment.This was resolved by placement of a pipeline flex starting more distal and brought well into and past existing pipeline.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE) MEDTRONIC; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine 92618 ; 9498373700
• MDR Report Key: 5209782
• MDR Text Key: 30683063
• Report Number: 2029214-2015-05116
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• 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
• Patient Age: 00080 YR
• Patient Weight: 67