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

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 06/20/2016

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.The device performed as intended; as indicated by successful deployment of the device.No device issue was reported during the procedure.Attempts were made to obtain additional information; however, our attempts were unsuccessful.Intracranial hemorrhage is a known inherent risk of endovascular procedure and is documented in the devices instruction for use.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.

Event Description

Citation: treatment of complex anterior cerebral artery aneurysms with pipeline flow diversion: mid-term results.Dabus g1,2,3, grossberg ja4, cawley cm.J neurointerv surg.2017 feb;9(2):147-151.Doi: 10.1136/neurintsurg-2016-012519.Epub 2016 jul 5.Medtronic received the following: one patient (age was early 50's) had a large intraparenchymal hemorrhage distal to the site of the aneurysm (acom), in the parietal region, 48 hours after the procedure and died consequently (major event).The aneurysm was 11.1 and was located in the acom region.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 6428142
• MDR Text Key: 70680833
• Report Number: 2029214-2017-00209
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• 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: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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