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

Model Number PED2-350-20

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 12/19/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the distal end of the pipeline failed to open and was unable to be resheathed.The patient was undergoing treatment for a previously ruptured saccular aneurysm.The aneurysm had been coiled in (b)(6) 2021.The max diameter was 13mmx9mm, and the neck diameter was 4.9mm.The patient's vessel tortuosity was minimal.The landing zone was 3.36mm distal and 3.66mm proximal.The access vessel was the left ica, which was 3.66mm in diameter. dual antiplatelet treatment was administered.It was reported that the pipeline could not be deployed due to not opening of ptfe sleeve.Resheathing was attempted, but the pipeline couldn't be resheathed.The pipeline was pulled back in to the navien and resheathing was again attempted, but it failed again.The device was completely removed outside to inspect, and when the marksman was inspected there was wrinkling in the distal part of the catheter.The pipeline was not positioned in a bend, and less than 50% had been deployed when it failed to open.The pipeline was resheathed two or less times. the patient did not experience any injury or complications.Angiographic results post procedure were said to be satisfactory.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a navien guide catheter, marksman microcatheter, and traxcess guidewire.

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: 13079083
• MDR Text Key: 290451263
• Report Number: 2029214-2021-01671
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• 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: 03/16/2024
• Device Model Number: PED2-350-20
• Device Catalogue Number: PED2-350-20
• Device Lot Number: B176960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 03/17/2021
• 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 Age: 60 YR
• Patient Sex: Female