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

Model Number PED-400-14

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The device has been returned.Analysis is pending.A follow-up mdr will be submitted when the investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex pushwire separation.The patient was undergoing treatment for an unruptured, saccular aneurysm in the ophthalmic artery (ica.) vessel tortuosity was described as moderate.The devices were prepared as indicated in the ifu.During the procedure, it was reported that the pipeline flex braid was implanted without any reported issues.It was also reported that the pipeline flex pushwire separated at hypotube proximal to wire weld ("from the resheathing pad up"), after the pipeline was deployed.A retrieval device was used to remove the separated segment of the pushwire from the patient.There were no reports of patient symptoms in association with this event.Angiographic results post-procedure were reportedly very good.

Manufacturer Narrative

The device was reported to have been discarded at the site.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Updated codes in section 6.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.

• 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: 9303083
• MDR Text Key: 165812653
• Report Number: 2029214-2019-01110
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015845
• UDI-Public: 00847536015845
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: PED-400-14
• Device Lot Number: A882134
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention