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

Model Number PED-500-25

Device Problem Activation Failure (3270)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding four pipeline devices that failed to open.The patient was undergoing a flow diversion procedure to treat an unruptured saccular aneurysm of the cavernous segment of an internal carotid artery (icu).The aneurysm max diameter was 14mm and the neck diameter was 8mm.The patient's vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered with noted pru level of 160.It was reported that the second attempt to implant flow diverter was made with a 5 x 25mm pipeline (model: ped-500-25, lot: b067560).As had occurred with the first device, there was failure of the distal end to open and a noted "cigar" shape with more than 50% of the device deployed when it failed to open.The middle section of this pipeline was placed in a vessel bend.The pipeline was resheathed more than 2 times and redeployed but still did not open.No other additional steps or devices were tried to open this pipeline.It was resheathed and removed with the phenom microcatheter.There were no patient symptoms or complications reported related to the event.Post-procedure angiography revealed no issue.The aneurysm remained unruptured and there was no evidence of damage from the devices.

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 indicated there was resistance felt with all four pipeline devices.A continuous flush had been administered during the procedure, and no other treatment was required for the patient at the time of the report.It was noted the physician may reschedule the patient with a different manufacturer.

• 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: 11047496
• MDR Text Key: 223625109
• Report Number: 2029214-2020-01351
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 08/10/2023
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: B067560
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR