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

Model Number PED-300-12

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

Patient Problems Death (1802); Hematoma (1884); Intracranial Hemorrhage (1891)

Event Date 10/21/2017

Event Type  Death  

Manufacturer Narrative

The pipeline device remained inside the patient, therefore, no product evaluation will be performed.Based on the reported information, the clinical observation dose not appear to be related to a device malfunction.However, the cause of the patient event could not be conclusively determined with the available information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a patient expired 15 days status post pipeline implant for treatment of a cerebral aneurysm at mca measured 8mm x 7mm.It was reported the pipeline device was prepared as indicated in the ifu.During the flow diversion procedure, no product issue was encountered.The pipeline was place at left mca bifurcation.The patient had a successful pipeline implant as evident by post op imaging.This patient had prior history of a-fib and had been on antiplatelet therapy.Prior to the pipeline implant procedure, patient did not have any neurological deficit.Besides a groin hematoma formation that required application of a fem stop and massage, there were no other perioperative events.Patient was discharged from the hospital on the following day at baseline with no neurological deficits.The patient's post flow diversion triple antiplatelet therapy (tapt) was managed in consultation with a cardiologist and a pharmacist.Patient was diagnosed with intracranial hemorrhage by ct scan at a different hospital on the day she expired.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDEN, IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDEN, IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7044802
• MDR Text Key: 92490157
• Report Number: 2029214-2017-01274
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2019
• Device Model Number: PED-300-12
• Device Lot Number: A328602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 118