MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-14

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has been returned for evaluation.A follow-up mdr will be submitted when the investigation is complete.Mdrs related to this event: 2029214-2019-01137.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that a pipeline flex device did not open at the distal end.The device was removed.The procedure was completed using new devices with good results.The patient was undergoing embolization treatment for an unruptured saccular posterior communicating artery aneurysm.The vessel was observed severely tortuous.The pipeline and any accessory devices were prepared as indicated in the ifu.There were not any patient symptoms or complications associated with this event.

Manufacturer Narrative

It was reported that both pipeline flex devices did not open during the procedure at the distal segment and were removed from the patient.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to investigate the event and/or determine the cause of the event.The health care provider and the manufacturer representative were contacted to obtain additional event details.The device was returned as part of this investigation.Analysis found the pipeline flex was not confirmed to have failure to open at the distal end.The event cause could not be determined as the distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.The pipeline flex braid returned without the pushwire or catheter.No other anomalies were observed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The damage to the braid on the ends of the pipeline flex is likely the result of the physician re-sheathing the device more than the recommended two times.It is likely that the severe vessel tortuosity may have contributed to the failure to open.The investigation determined that this was a known event.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.Reference the following mdrs: 2029214-2020-00018 2029214-2020-00019 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9333617
• MDR Text Key: 186751949
• Report Number: 2029214-2019-01138
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016651
• UDI-Public: 00847536016651
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: PED-475-14
• Device Lot Number: A864459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1