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

Model Number PED2-300-16

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 12/15/2021

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 proximal part of the pipeline pushwire became stuck during retraction and the pipeline moved out of position. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left m1 segment. The max diameter was 2mm, and the neck diameter was 3mm. The patient's vessel tortuosity was moderate. The landing zone was 3mm distal and 3. 25mm proximal.  dual antiplatelet treatment was administered. It was reported that once the device was positioned in the m2 artery, it was deployed by correctly positioning the device in distal m1 and proximal m1 with optimal deployment, covering the neck correctly. When checking the tip and the delivery system it was noted that the device was attached in its area proximal to the delivery system (region of the recapture pad) when making controlled maneuvers to detach it from it to recapture pad with the microcatheter and the delivery system. A sudden proximal shortening of the device was observed, which caused its final location to be below the neck of the aneurysm. Immediately afterwards, the delivery system was removed and another device of the same size was implanted in a distal m1 position, covering the neck without any inconvenience. There was no damage to the catheter or pushwire, and the pushwire had been rotated during removal.  no additional medical/surgical interventions or prolonged hospitalization was required as a result of the event.  the patient did not experience any injury or complications. Angiographic results post procedure showed ineffective coverage of the aneurysm neck with a stent pipeline compacted to the proximal region of the neck of the aneurysm. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a cook shuttlesheath, navien guide catheter, and phenom 27 microcatheter.

• 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: 13053745
• MDR Text Key: 288496697
• Report Number: 2029214-2021-01643
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-300-16
• Device Catalogue Number: PED2-300-16
• Device Lot Number: B039414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial