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 Headache (1880); Hemorrhage, Subarachnoid (1893); Vascular Dissection (3160)

Event Type  Injury  

Event Description

Information received from the article: jones et al.Prevention of stent thrombosis with reduced dose of prasugrel in two patients undergoing treatment of cerebral aneurysms with pipeline embolisation devices.Bmj case reports 2012.Medtronic (covidien) received information through literature review regarding manufactured product and the adverse event involved with it.Five days post procedure involving two overlapping pipelines, the patient experienced severe headaches and was found to have a small right frontal subarachnoid bleed over the convexity remote from the aneurysm.Prior to the adverse event and during the initial procedure, repeat angiography revealed cervical petrous dissection with flow limitation and an acculink stent was deployed across the dissection.Final angiography demonstrated stent patency and significant stasis within the aneurysm.After the patient complained of the headaches and the bleed was found, repeat cerebral angiography displayed significant aneurysm thrombosis when compared with previous 3d prior.The patient was continued on dual antiplatelet therapy during hospitalization and received 6 months of dual antiplatelet therapy after discharge.The treatment was for a giant aneurysm located in the cavernous segment of the right ica (internal carotid artery).No further complications were reported.

Manufacturer Narrative

The report was created to capture the post procedure complications.The information was received from the article: jones et al.Prevention of stent thrombosis with reduced dose of prasugrel in two patients undergoing treatment of cerebral aneurysms with pipeline embolisation devices.(b)(4).The lot history record review was not possible as the lot number was not reported.(b)(4).

• 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: 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4547333
• MDR Text Key: 5511447
• Report Number: 2029214-2015-00206
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2015

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: 01/27/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 50 YR