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

Model Number PED2-425-12

Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 09/28/2021

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 pipeline failed to open distally, and the distal tip of the device appeared to be damaged.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica superior hypophyseal.The max diameter and neck diameter were 4mm.The patient's vessel tortuosity was minimal.The landing zone was 3.4mm distal and 4.2mm proximal.It was reported that the 4.25mm pipeline did not become close to apposing the 3.4mm diameter vessel distally.The pipeline was not p ositioned in a bend, and more than 50% was deployed when it failed to open.The pipeline was resheathed more than 2 times, and no additional steps were taken to open the device.The device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed that vessel wall apposition and aneurysm coverage were achieved.It was noted that the devices were not prepared according to the instructions for use (ifu) as the physician flipped ptfe in a bowl of saline on the back table prior to deploying the device in the patient.Ancillary devices include a phenom plus guide catheter and a phenom 27 microcatheter.

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.

Event Description

Additional information received reported the pipeline sleeve was flipped in a bowl of saline on the back table prior to insertion into delivery microcatheter.The distal end of the braid therefore was not protected and could not have gotten damaged, there was friction or difficulty during delivery or positioning.

• 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: 12577358
• MDR Text Key: 274779530
• Report Number: 2029214-2021-01236
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284411
• UDI-Public: 00763000284411
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2024
• Device Model Number: PED2-425-12
• Device Catalogue Number: PED2-425-12
• Device Lot Number: B244946
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1