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

Model Number PED2-425-25

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

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline that failed to open at the distal and end became stuck in the microcatheter during resheathing.The patient was being treated for an unruptured amorphous aneurysm of the right carotid artery.The aneurysm max diameter was 26mm and the neck diameter was 15mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that all devices were prepared per instructions for use (ifu).When deploying the pipeline device, the distal end failed to open.The pipeline then became stuck in the middle of the microcatheter when it was being resheathed.The physician released the slack in the delivery system but this did not resolve the issue.The pipeline was removed and replaced to continue the procedure.There was no damage noted to the pipeline pushwire.During the procedure, the catheter was flushed continuously with heparinized saline.There was no damage observed to the catheter.There was no harm or injury to the patient.No additional medical or surgical intervention was required and there was no extension of the patient's hospitalization related to the event.Post-procedure angiography showed successful device implantation.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10936168
• MDR Text Key: 219523461
• Report Number: 2029214-2020-01223
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: PED2-425-25
• Device Catalogue Number: PED2-425-25
• Device Lot Number: A610236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/02/2020
• Date Device Manufactured: 03/09/2018
• 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