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

Model Number PED2-500-30

Device Problem Activation Failure (3270)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the product was used during fd implantation.The sleeve was removed with m1.Using m1 as it is, the distal end was attempted to be expanded by repeatedly pulling and pushing.However, the distal end could not be opened.Full resheath was also attempted about 3 times, but it could not be opened.It was in a form that could not be expanded without anchoring the tip, so a push/pull was performed several times afterwards.It was attempted again with ic-top, but the tip did not open, so it was collected.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed 3 or more times.No operation or other device was used to deploy the stent.The stent was resheathed and removed from the patient's body with the microcatheter.No patient symptoms or further complications were reported as a result of this event.The pipeline was not used for an indication that is not approved (off-label).The device was prepared as indicated in the package insert.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ic-cavernous of the left internal carotid artery with a max diameter of 18mm and a 8mm neck diameter.Blood vessel diameter in the landing zone was 4.5mm on the distal side and 5.25mm on the proximal side.It was noted the patient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered with pru level of 120.There was no change to the postoperative findings related to blood flow contrast.

Manufacturer Narrative

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: 13079366
• MDR Text Key: 287008468
• Report Number: 2029214-2021-01672
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B093049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 09/28/2020
• 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: 62 YR
• Patient Sex: Female