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

Model Number PED-425-25

Device Problem Activation Failure (3270)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the distal section of the pipeline flex device opened well.Therefore, the physician decided to continue the deployment across the neck of the aneurysm.However, the device did not open, physician re-sheathed and another attempt to open it was made, but still the device did not open.The physician decided to remove the pipeline flex and used a new pipeline to treat the patient.The pipeline flex and any accessory devices were prepared as indicated in the instructions for use (ifu).More than 50% of the device was deployed when the proximal section failed to open.The device was resheathed less than or equal to 2 times.No additional steps were made to open the device.This event occurred during the treatment of a left vertebral artery, saccular, unruptured aneurysm.The max diameter was 14mm and the neck was 4mm.The distal landing zone was 3.4mm and the proximal3.9mm.The vessel anatomy was moderate in tortuosity.

Manufacturer Narrative

D10.Device available; return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation; device returned - additional information h6.Evaluation codes - additional information; device evaluation h10.Additional manufacturer narrative - additional information; device evaluation the pipeline flex was returned with the distal and proximal dps restraints intact.There were no signs of damage found on the dps sl eeves.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex braid appeared to be fully opened and moderately frayed.No bend was observed on the pushwire.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the analysis findings, the pipeline flex was not confirmed to have failure to open at the proximal end as the proximal end of the pipeline flex braid was found fully opened and moderately frayed.However, the cause for damage could not be determined.It is likely that the patient tortuous anatomy may have contributed to the failure to open issue.There was no non-conformance to specifications identified that led to the reported issue.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: 9511020
• MDR Text Key: 184509410
• Report Number: 2029214-2019-01286
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015821
• UDI-Public: 00836462015821
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: PED-425-25
• Device Catalogue Number: PED-425-25
• Device Lot Number: A792498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1