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

Model Number PED-375-20

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 05/30/2021

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 after 10-15mm the pipeline opened slowly but did not open well, so the physician retrieved the stent and tried to open the wings with the tip of the marksman.It was initially difficult to retrieve but then was gently swayed and re-opened again, during which displacement occurred.The stent and tip of the catheter moved to before the bifurcation of the middle cerebral artery, and still did not open well.Balloon angioplasty was then attempted, but the stent slid into the internal carotid artery, so the stent was retrieved into the marksman.However, the stent became stuck at the micorcatheter tip open retrieval and could not be separated.As a result the pipeline and marksman were replaced to complete the procedure.The distal portion of the microcatheter was found to have kink damage.The patient was undergoing treatment of an unruptured, amorphous right opthalmic artery segment aneurysm with a max diameter of 7mm and a neck width of 3.6mm.It was noted that the patient's vessel tortuosity was moderate.A continuous flush was used and the devices were prepared per the ifu.There were no related patient symptoms.Post procedure angiographic results showed an unobstructed tumor-bearing artery, a positive outcome.

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.

Event Description

Additional information received reported there was no resistance during delivery.The pipeline was not positioned in a vessel bend; it was in a horizontal segment of the m1.It was only one pipeline being used with was moved when withdrawing the catheter.

Manufacturer Narrative

H3.Product analysis: the pipeline flex embolization device was returned within the marksman catheter.The pipeline flex pusher was extending from within the marksman catheter hub for ~46.4cm.The marksman catheter body was damaged at ~39.4cm from the distal tip and from ~29.4cm to ~24.5cm from the distal tip.The pipeline flex braid was partially deployed from within the marksman distal tip.The pipeline flex embolization device was pushed out from within the marksman catheter, fully deploying the braid.The pipeline flex pusher was found intact.Dried residue, likely blood, was found on the pusher resheathing pad.The pipeline flex braid was found fully open and in good condition.The pusher ptfe sleeves and tip coil were found in good condition.Based on the device analysis and reported information, the customer's "failure/incomplete open distal" report could not be confirmed as the device has been fully deployed and re-sheathed.In addition, the pipeline flex braid was found fully open.It is possible the patient's "moderate" vessel tortuosity contributed to the event; however, the cause could not be determined.The issues were confirmed regarding the customer's reports of "resistance." from the damages seen with the marksman catheter, it appears high force was used.These damages likely occurred when the customer attempted to advance/retrieve the pipeline flex through the marksman catheter against resistance.The investigation determined that these events were similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies.It is possible the patient's "moderate" vessel tortuosity contributed to the reported resistance; however, the cause for the resistance could not be determined.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: 11913562
• MDR Text Key: 253533150
• Report Number: 2029214-2021-00640
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015661
• UDI-Public: 00847536015661
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: PED-375-20
• Device Catalogue Number: PED-375-20
• Device Lot Number: B163247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR