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

Model Number PED2-325-12

Device Problems Positioning Failure (1158); Component or Accessory Incompatibility (2897); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem Bradycardia (1751)

Event Date 12/07/2021

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 pipeline failed to open. The patient was undergoing treatment for a ruptured, amorphous aneurysm located in the right ica. The max diameter and neck diameter were 6mm. The patient's vessel tortuosity was moderate. The landing zone was 2. 9mm distal and 3. 0mm proximal.  dual antiplatelet treatment was administered, and the radiologist was satisfied with the pru levels. It was reported that the procedure was initially an acute case, but the radiologist wanted to try to place a coil. Therefore, a sheath and navien were placed, 3d performed and a phenom 27 microcatheter was taken into the m2/3 branch. The echelon microcatheter was placed into the aneurysm. There was difficulty navigating past the aneurysm and wires kept popping into the lesion, but this did not cause any issues. The pipeline was initially opened in the m1 region. The stent opened slightly distally but not fully, likely restricted by the size of vessel and position. The pipeline was drawn back into terminal ica and looked to be opened slightly better. However, it was difficult to visualize and appeared not to be opening well in mid section. The patient then experienced a short bradycardia event, but anesthetist checked patient and this resolved quickly after a minute. A further attempt was made to open; however, the radiologist was unhappy with how it performed. Resheathing was attempted; however, the system was on a bend and they felt the device was on an angle and it would not resheath smoothly. They decided something was not right with device and removed it. They were able to resheath with one gently further attempt. It was decided to remove the echelon catheter and abandon the coiling element as it was thought to be likely not required and was potentially adding additional difficulty and hindering deployment of stent. A phenom 21 system was placed with a new pipeline. They opened it in the m2/1 initially and dragged it back to the proximal m1 with the intention to drop it there and into the ica, avoiding perforators. The device opened well distally and throughout to good result.  it was noted that there was a stenotic segment at the distal ica. The radiologist had advised that dropping at the terminal ica stent may potentially slip back due to vessel shape, so a second stent was deployed in m1. The patient did not experience any injury. Angiographic results post procedure were said to be good. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a neuron max sheath, navien 72 guide catheter, echelon 10 microcatheter, phenom 27 microcatheter, traxcess 14 guidewire, and synchro 14 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12991871
• MDR Text Key: 283689141
• Report Number: 2029214-2021-01603
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-325-12
• Device Catalogue Number: PED2-325-12
• Device Lot Number: B011805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial