MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-16

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

Patient Problems Neurological Deficit/Dysfunction (1982); Perforation (2001)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

The reported device remains implanted in the patient.Product evaluation will not be performed.This is a report involved multiple devices from medtronic and other manufacturer.The cause of the clinical experience cannot be conclusively determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a patient had right middle cerebral artery rupture during the treatment of a cerebral aneurysm.This patient had a fusiform aneurysm measured 7mm in max diameter located at the right mca, m1 m2 bifurcation.Due to the location of the patient's aneurysm, the treatment plan was to place a pipeline flex embolization device (ped) for flow diversion at m1/m2, and a non-medtronic stent into m2 to adjunct the flow diversion.This patient's vessel tortuosity was described as moderate.At the procedure, the ped was successfully implanted at right mca m1/m2.The physician went on and placed the non-medtronic stent distally to the ped at m2 as planned.A non-medtronic balloon catheter was then advanced and inflated to anchor the non-medtronic stent.During this process, the patient's mca ruptured at the proximal end of the non-medtronic stent at m1.The ruptured mca was coiled off to stop the bleeding.The patient was then sent to surgery for a bypass.There was change in patient's neurological function post operatively, but details were not provided.The ped remains implanted in the patient.There was no alleged product issue.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN, IRVINE; 9775 toledo; irvine CA
• Manufacturer (Section G): COVIDIEN, IRVINE; 9775 toledo; irvine CA
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7177198
• MDR Text Key: 96809746
• Report Number: 2029214-2018-00026
• 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
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: PED-500-16
• Device Lot Number: A465094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2017
• 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
• Patient Age: 47 YR
• Patient Weight: 86