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

Model Number PED2-475-20

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the distal part of the pipelined failed to deploy.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left internal carotid - paraclinoid.The max diameter was 6mm, and the neck diameter was 7mm.The patient's vessel tortuosity was moderate.The landing zone was 4mm distal and 5mm proximal.It was reported that the pipeline tip deployed well, but it was not deployed about 10mm from the tip.The device was at the distal end of a normal, straight part of the middle cerebral artery (mca).It was confirmed that the deployment on the way was defective.When deployment failure part was confirmed under fluoroscopy, it looked like a twist.Less than 50% of the device had been deployed at the time.After that, the device was resheathed twice at the same location, but the issue did not resolve.It was suspected that the pipeline was twisted at the time of retracting regardless of deployment method or angioarchitecture.The pipeline was removed and replaced.No other steps were taken to open the device. the patient did not experience any injury, and postoperative angiography showed no problems.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter and a fubuki 6f st dilator guide catheter.

Event Description

Additional information received reported there was no friction or other difficulty during delivery or positioning.

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.

Manufacturer Narrative

H3: the pipeline flex pusher ptfe sleeves and tip coil were found extending out from within the phenom 27 distal tip.No damage was found with the phenom 27 distal marker/tip.The pipeline flex pusher tip coil appears to be in good condition.The pipeline flex embolization device was pushed out from within the phenom 27 catheter, without issue, deploying the braid.No bends or kinks were found with the pipeline flex pusher.The pusher was found intact.The pipeline flex braid proximal end appears to be in good condition.However, the braid¿s distal end was found damaged (frayed).Both ends of the braid were found open.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12229603
• MDR Text Key: 263598887
• Report Number: 2029214-2021-00926
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: B036893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1