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

Model Number PED2-300-16

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 12/15/2021

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 proximal part of the pipeline pushwire became stuck during retraction and the pipeline moved out of position.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left m1 segment.The max diameter was 2mm, and the neck diameter was 3mm.The patient's vessel tortuosity was moderate.The landing zone was 3mm distal and 3.25mm proximal. dual antiplatelet treatment was administered.It was reported that once the device was positioned in the m2 artery, it was deployed by correctly positioning the device in distal m1 and proximal m1 with optimal deployment, covering the neck correctly.When checking the tip and the delivery system it was noted that the device was attached in its area proximal to the delivery system (region of the recapture pad) when making controlled maneuvers to detach it from it to recapture pad with the microcatheter and the delivery system.A sudden proximal shortening of the device was observed, which caused its final location to be below the neck of the aneurysm.Immediately afterwards, the delivery system was removed and another device of the same size was implanted in a distal m1 position, covering the neck without any inconvenience.There was no damage to the catheter or pushwire, and the pushwire had been rotated during removal. no additional medical/surgical interventions or prolonged hospitalization was required as a result of the event. the patient did not experience any injury or complications.Angiographic results post procedure showed ineffective coverage of the aneurysm neck with a stent pipeline compacted to the proximal region of the neck of the aneurysm.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a cook shuttlesheath, navien guide catheter, and phenom 27 microcatheter.

Event Description

(b)(6) 2021 mpxr 906983 (rep, hcp, for): medtronic received a report that the proximal part of the pipeline pushwire additional information reported there was no friction, what's more, the device was positioned according to the technique and recommendation.The catheter tip did not move, it was optimal deployment.

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.

• 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: 13053745
• MDR Text Key: 288496697
• Report Number: 2029214-2021-01643
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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: 06/12/2023
• Device Model Number: PED2-300-16
• Device Catalogue Number: PED2-300-16
• Device Lot Number: B039414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/13/2022
• Date Device Manufactured: 06/12/2020
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 54 KG