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

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

Patient Problems Air Embolism (1697); Inflammation (1932)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

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.Wfitn 2015 abstracts: poster display.(2015).Interventional neuroradiology, 21(1 suppl), 66-89.Doi:10.1177/1591019915618081 mdrs related to this article: 2029214-2016-00538 2029214-2016-00539.

Event Description

Medtronic received information from literature review of patient complications after pipeline implantation.The purpose of this article was to review the clinical experience of the pipeline embolization device.Records of 16 patients (mean age 66 years) treated with pipeline were reviewed.The aneurysms were unruptured and ranged in size from 1.5 to 3.6cm.The aneurysms were located in the carotid cavernous, carotid ophthalmic, posterior communicating, and supraclinoid.It was reported that air embolism occurred in one patient without significant neurological sequelae.In addition, one patient experienced ophthalmoplegia secondary to petrositis.

• 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: 5781444
• MDR Text Key: 49125408
• Report Number: 2029214-2016-00539
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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
• Report Date: 06/13/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/10/2016
• 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): Other
• Patient Age: 66 YR