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

Model Number PED-475-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that pipeline flex delivery system broke off at re-sheathing pad.It was reported that after pipeline flex was deployed, the physician attempted to recapture delivery system in straight m1 segment, met significant resistance, stopped and pulled it and microcatheter out.Upon inspection on back table, delivery system broke off at re-sheathing pad.The device open and placed where physician intended.There were not any patient symptoms or complications associated with this event.Dapt (dual antiplatelet treatment) was administered.The pru level was in normal range.No images available for review.The patient was undergoing embolization treatment for a small unruptured saccular para ophthalmic aneurysm, measuring 10mmx6mm, landing zone distal 4.0mm, proximal 4.8mm.The vessel observed normal tortuous.No patient injury was reported.The pipeline and any accessory devices were prepared as indicated in the ifu.

Event Description

Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated all of the broken segment of was removed from the patient.The lot number of the catheter was unknown and it was discarded.

Manufacturer Narrative

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: 10190735
• MDR Text Key: 201695638
• Report Number: 2029214-2020-00596
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015586
• UDI-Public: 00836462015586
• 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: 07/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: PED-475-16
• Device Catalogue Number: PED-475-16
• Device Lot Number: A767238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1