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

Model Number PED3-027-550-20

Device Problems Positioning Failure (1158); Retraction Problem (1536); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 04/19/2024

Event Type  malfunction  

Event Description

Medtronic received a report that devices were prepared as per instructions for use (ifu) guidelines.Access was taken in middle cere bral artery (mca) with phenom and synchro.Pipeline vantage 5.5x20 was positioned from mca origin and deployment was planned from internal carotid artery (ica) terminus to post cavernous bend.Distal segment opened and with a few extra mms, wall apposition was happening.Across the neck (at a tortuous bend) and in the proximal segment, the stent failed to open after multiple resheathings, exchange and wagging technique attempts.While resheathing in the last attempt, access was lost from mca so it was decided to take the device completely out and get access with synchro wire again.While recapturing the device in its white protective sleeves, the stent was getting stuck from the proximal end.Now the sleeve was taken out and the stent opened.There was resistance in the catheter at the hub and in the proximal section.The catheter was flushed continuously with heparanized saline.The pipeline became stuck at the hub during resheathing.The physician released the load (slack) in the system in an attempt to resolve the issue, but this did not resolve the issue.There was no damage observed to the catheter or pushwire.There was failure to open in the middle and proximal s ections of the pipeline.The middle and proximal sections were positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed more than two times.There were no additional steps or other devices required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.The pipeline was used for an approved indication.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a blister, ruptured c6 left ica aneurysm with a max diameter of 1.4mm and a 2mm neck diameter.The landing zone was 4.8mm distally and 5.1mm proximally.It was noted the patient's vessel tortuosity wassevere.Dual antiplatelet therapy (dapt) was administered, platelet reactivity units (pru) level was 180.Angiographic result post procedure was that distal vessels had a normal blood flow.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received reported that access was lost from mca meant ¿ during procedure, pipeline¿s distal tip coil wire is generally in the distal artery (in this case mca branch).During the case, while maneuvering to resheath the device, the entire system fell from mca when the doctor must have pulled the device hence causing the tip coil to end up around the ophthalmic segment.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PIPELINE VANTAGE WITH 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: 19155473
• MDR Text Key: 341540638
• Report Number: 2029214-2024-00722
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-550-20
• Device Catalogue Number: PED3-027-550-20
• Device Lot Number: B623137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Date Device Manufactured: 09/09/2023
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 59 KG