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

Model Number PED2-375-10

Device Problems Retraction Problem (1536); Malposition of Device (2616); Physical Resistance/Sticking (4012)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id unk-nv-fg (lot: unknown); product type: ; implant date n/a; explant date n/a.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

Medtronic received a report that the pipeline encountered resistance in the catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery (ica) between the pcom and ophthalmic with a max diameter of 2.5mm and a 2.5mm neck diameter.The landing zone was 3.6mm distally and 3.8mm proximally.It was noted the patient's vessel tortuosity was normal.It was reported that they started deployment in the m2 exposing braid and it opened up nicely like normal, then the doctor dragged the device down to the terminus ended up too proximal of the desired distal landing zone.Needing to adjust, the doctor recaptured the tip coil, then adjusted his position and they tried to un-sheath tip coil.The doctor said he had very hard resistance and the device would not re-deploy out of the phenom 27.He pulled out the phenom 27 system with the device still inside.The doctor started over with new phenom 27 and new device 3.75x14 which deployed like normal with no issues.It was noted that the pipeline was stuck in the catheter in the distal section during resheathing.The catheter was flushed continuously with heparanized saline.The physician released the load in the system in attempt to resolve the issue, however, the issue was not resolved.It was noted that the distal section of the catheter was damaged as the pipeline was lodged at the distal end of the phenom 27 and was noted it may be kinked.The pushwire was not damaged.The pushwire/capture coil was stuck during retraction in the distal end of the phenom.The pushwire was not rotated during removal.The pipeline was used for an indication that is approved (on-label).The reported devices and any accessory devices prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a sheath, navien 58 guide catheter, phenom 27 microcatheter, and synchro select guidewire.

• 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: 19000081
• MDR Text Key: 339127973
• Report Number: 2029214-2024-00533
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284220
• UDI-Public: 00763000284220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-375-10
• Device Catalogue Number: PED2-375-10
• Device Lot Number: B632331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Date Device Manufactured: 08/01/2023
• 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
• Treatment: SEE H11...
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 76 KG