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

Model Number PED2-500-14

Device Problem Activation Failure (3270)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 pipeline flex with shield did not expand in the middle section.Difficult sizing because of the structure of the aneurysm and the vessel conditions.Decision to use a ped2-500-14.While deploying the pipeline shows over the aneurysm neck a fold that could not be removed.Even with resheating and new placement.Due to this behavior the foreshortening was so strong, that the device was not able to cover the whole vessel part which was planned to treat.Decision to use another size and device with no problems in placement and good result.The devices were prepared and used per the instructions for use (ifu).The vessel anatomy was moderate in tortuosity.This event occurred during the treatment of a left ica, unruptured, fusiform aneurysm.The distal landing zone was 4.5mm and the proximal was 5.2mm.No patient injury occurred.

Manufacturer Narrative

The pipeline flex shield was returned.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.The distal and proximal ends of the pipeline flex shield braid were found opened and moderately frayed.The middle section of the pipeline flex shield braid appeared fully opened and no damage.No defects 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 shield was not confirmed to have failure to open at the middle section.The event cause could not be determined as the middle section of the braid appeared fully opened with no damage.In addition, the distal and proximal ends of the braid appeared fully opened and moderately frayed.However, the cause for damage could not be determined.It is possible that the patient tortuous anatomy may have contributed to the failure to open 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 WITH SHIELD
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9397772
• MDR Text Key: 186758207
• Report Number: 2029214-2019-01181
• Device Sequence Number: 1
• Product Code: OUT
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: PED2-500-14
• Device Lot Number: A710149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1