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

Model Number PED-400-20

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 12/22/2020

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 delivery system became stuck during retraction and the pushwire was found to be broken at the hypotube proximal to the wire weld.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left paraopthalmic artery.The max diameter was 5 mm, and the neck diameter was 4 mm.The patient's vessel tortuosity was moderate.Dual antiplatelet treatment had been administered, and the pru level was 8.The landing zone was 3.2 mm distal and 3.8 mm proximal.The access vessel was radial and 3 mm in diameter.It was reported that the pipeline ptfe sleeves caught inside distal navien.They could not pull pipeline wire out through navien, and they had to cork pipeline wire and pull entire system out.Upon evaluation the pipeline wire separated from wire at proximal point of no return.The pushwire/capture coil was stuck during retraction.The pushwire was rotated during removal.There was no damage to the catheter, but the pushwire was broken and detached at the hypotube proximal to the wire weld.The broken segment was removed from the patient through the catheter.There were no issues with the actual pipeline deployment, no patient issues related to this event, and the case was otherwise uneventful.The event occurred while removing system from patient proximal to petrous ica.The stent had been deployed successfully, and the issue was contained within the navien catheter and removed from the patient successfully.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Angiographic results post procedure showed no issues.Ancillary devices include a navien 058 guide catheter, phenom 27 microcatheter, and infinity 088 90cm sheath.

Manufacturer Narrative

H6: method code updated to b18.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 the pipeline pushwire was discarded.

• 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: 11114405
• MDR Text Key: 225063515
• Report Number: 2029214-2021-00007
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A852545
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR