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

Model Number PED-425-20

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the distal part of the pipeline pushwire broke.The patient was being treated for an unruptured, saccular aneurysm of the right ica.The max diameter and neck diameter were 3 mm.Dapt was administered and pru level was 170.Patient vessel tortuosity was minimal.The landing zone was 3.9 mm distal and 4.2 mm proximal.The phenom 27 was navigated to the desired location.The physician deployed the pipeline with no problem.While trying to retrieve the ped pushwire using the phenom 27 in order to finish the procedure, the physician said they felt a little tension and they said they felt something broke.This occurred when he was resheathing the distal tip of the pushwire inside the phenom 27.The angiographic images didn't show any fracture.The physician removed the pushwire as usual, with no additional maneuvers required and with no complications.Once the phenom 27 and the pushwire were out of the patient, the physician noticed the fracture of the distal portion of the pushwire (close to the resheating pad).There was friction/difficulty during retrieval, but it was said to be minimal.The pushwire segment was removed with the catheter and the procedure was completed successfully.All devices had been prepared and the catheter flushed per the instructions for use (ifu).There was no harm or injury to the patient.Post-procedure angiographic results were normal.Ancillary devices include a nueron max 088 sheath and phenom 27 microcatheter.

• Brand Name: PIPELINE FLEX
• 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: 11114599
• MDR Text Key: 225062970
• Report Number: 2029214-2021-00008
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P100018.S011
• 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: 01/04/2021

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: 04/25/2022
• Device Model Number: PED-425-20
• Device Catalogue Number: PED-425-20
• Device Lot Number: A821514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/04/2021
• Date Device Manufactured: 04/26/2019
• 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: 57 YR
• Patient Weight: 75