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

Model Number PED2-400-20

Device Problem Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that they were delivering the diverter and the entire system fell from the carotid to the aorta, without incident for the patient but losing the material in the patient's body.The pipeline was not implanted in the intended location.No patient symptoms or further complications were reported as a result of this event.The device was used for on-label use and the device and accessories were prepared per ifu.Dapt (dual antiplatelet treatment) was administered and the pru level was "ass-pras." angiographic result post procedure was patent aneurysm and missing device.  the patient was undergoing surgery for treatment of an unruptured aneurysm in the carotid int with a max diameter of 10mm and a 7mm neck diameter.Landing zone was 3.5mm distally and 4.1mm proximally.It was noted the patient's vessel tortuosity was severe.Ancillary devices include a phenom27 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 that when trying to remove the device through the introducer, it, being partially released (distal end), remained positioned in the deep femoral artery.The a neurysm was anterior choroidal with a distal vessel: 2.28mm (m1) and proximal vessel: 4.13 mm (carot).Tortuosity: severe in the aortic arch and moderate in the carotid.It was noted that the main problem was a fall of the system during deployment and due to the impossibility of repositioning it distally to restart the technique, the doctor tried to remove the device through the femoral introducer (not a 7fr guide catheter) this caused the device to remain in the femoral artery without any type of complication , symptom or injury to the patient.Remains with double antiaggregation.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14018462
• MDR Text Key: 292384383
• Report Number: 2029214-2022-00586
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-400-20
• Device Catalogue Number: PED2-400-20
• Device Lot Number: B255427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female