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 Problem Hemorrhage, Cerebral (1889)

Event Date 06/02/2016

Event Type  Death  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted 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 could not be conclusively determined from the reported information.Burrows, a.M.Et al.(2016, june 02).Flow diversion for ophthalmic artery aneurysms.American journal of neuroradiology, 37(10), 1866-1869.Mdrs related to this article: 2029214-2016-01070 2029214-2016-01071.

Event Description

Medtronic received information from literature that a patient died after flow diversion treatment.The purpose of this article was to evaluate the outcomes of patients with carotid-ophthalmic aneurysms treated with flow diversion.The article evaluated 50 carotid-ophthalmic aneurysms in 48 patients; 46 of the aneurysms in 44 patients received treatment.Forty five of the aneurysms were treated with the pipeline embolization device (ped) and 1 aneurysm was treated with another manufacturer¿s device.Mean age was 52 years; 41 of the aneurysms were found in women.The authors stated that at 12 days post-implantation, one patient with a 21mm aneurysm died of a delayed distal intraparenchymal hemorrhage not related to aneurysm rupture.The authors stated this death was procedure-related.

• 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: 6130988
• MDR Text Key: 60988437
• Report Number: 2029214-2016-01071
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• 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: 11/01/2016
• 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): Death