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

Model Number PED-425-25

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 09/16/2021

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 was kinked/twisted in the proximal/mid section and failed to open in the middle.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the right ica ophthalmic segment.The max diameter was 12mm, and the neck diameter was 9mm.The patient's vessel tortuosity was severe.The landing zone was 3.06mm distal and 4.15mm proximal. dual antiplatelet treatment was administered, and the pru level was 61.It was reported that the middle part of the pipeline was positioned in a bend, and more than 50% had been deployed when it failed to open.The pipeline had been resheathed more than 2 times.There were no additional steps taken to open the device.The device was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed stasis in the aneurysm, and the device was well apposed.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a bmx 80cm sheath, navien.072 guide catheter, phenom 27 microcatheter, and aristotle 14 guidewire.

Event Description

Additional information received reported that there were no issues that resulted in the damage that was found, just tortuous anatomy.There was no friction during delivery or positioning, but the device kept linking in the distal turn and the more proximal turn.

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.

• 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: 12506283
• MDR Text Key: 272495034
• Report Number: 2029214-2021-01183
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016231
• UDI-Public: 00847536016231
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: PED-425-25
• Device Catalogue Number: PED-425-25
• Device Lot Number: B009776
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 112