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

Model Number PED-425-20

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 10/29/2016

Event Type  Death  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it was implanted in the patient.From the reported information, there did not appear to be any device issues during implantation.The iph occurred in the patient post-implantation and the cause could not be conclusively determined from the provided information.

Event Description

Medtronic received report that a patient experienced an intraparenchymal hemorrhage after pipeline flex implantation.The patient underwent pipeline flex implantation to treat an aneurysm in the supraclinoid internal carotid artery (ica).It was reported that two days after implantation, the patient experienced an intraparenchymal hemorrhage.The patient passed away the same day.

Event Description

Medtronic received additional event information: after experiencing an intraparenchymal hemorrhage (iph) in an unknown location, the patient received palliative care and later passed away.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX 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: 6168718
• MDR Text Key: 62182056
• Report Number: 2029214-2016-01106
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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,Followup,Followup
• Report Date: 11/14/2016

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
• Device Expiration Date: 02/08/2018
• Device Model Number: PED-425-20
• Device Lot Number: A055020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided; 01/31/2017
• Supplement Dates FDA Received: 02/09/2017; 09/27/2017
• Date Device Manufactured: 02/09/2015
• 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): Death
• Patient Age: 72 YR