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

Model Number PED2-500-20

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

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

Event Date 04/02/2021

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2021-00432 for the other pipeline device used in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the two pipeline devices experienced resistance in the distal shaft of two phenom 27 microcatheters and did not open distally.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica.The max diameter was 12mm, and the neck diameter was 6mm.The patient's vessel tortuosity was moderate.The landing zone was 2.3mm distal and 3.9mm proximal.The access vessel was the ica, which was approximately 2-5mm in diameter.It was also noted that the pipeline was used off-label to treat an ic ophthalmic 12mm fusiform aneurysm.It was reported that there was strong resistance inside phenom catheter when inserting the central part of the pipeline, making it difficult to deliver.Also, although it reached the mca, the tip expansion was failure.There was stronger resistance when removing the sleeve.It was felt that there was risk of fracture of pushwire of the pipeline so it was removed.This happened to two pipeline and phenom devices in a row.Eventually, a pipeline of a reduced size was used and it was placed by overlapping.There had been no damage to the catheter or delivery pushwires.The devices were not located in a bend, and less than 50% of the pipeline had been deployed due to the poor distal deployment.The pipeline had been resheathed 2 times or less, and no additional steps were taken to deploy the device. the catheter was flushed with heparinized saline during the procedure. post operative blood flow angiography showed no change. the patient did not experience any injury.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a navien 5 fr guide catheter and chikai black soft tip 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11668974
• MDR Text Key: 245498863
• Report Number: 2029214-2021-00433
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B036895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Date Device Manufactured: 06/08/2020
• 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