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

Model Number PED2-500-14

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

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

See related regulatory report 2029214-2021-00743.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that initial deployment of the pipeline failed.As a result the device was resheathed and repositioned at a straight part of the vessel for a second deployment attempt, which resulted in the distal part of the device failing to open after over half of the device was deployed.At least 3 resheathing attempts were made, including allowing the pipeline some minutes to allow it to open, but it still failed to open.The system as also attempted to be "wagged" and pushed to relieve slack which also failed.The pipeline also became stuck during resheathing and retrieval from the microcatheter, causing accordion damage to the distal end of the marksman.The issue occurred with two pipeline devices, with the third device used working as intended with complete wall apposition.The patient was undergoing treatment of an unruptured, saccular ica aneurysm with a max diameter of 4.9mm and a neck width of 4.47mm.There was no vasospasm or further intervention required.A continuous flush was used.The patient's vessel tortuosity was moderate, and deployment was done in a slight curve.Dual antiplatelet treatment was administered, but the pru level was unknown.There were no related patient symptoms.

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 damage observed to the pipeline pushwire.

• 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: 12019495
• MDR Text Key: 263443275
• Report Number: 2029214-2021-00744
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: A815695
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1