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

Model Number PED2-450-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information reporting that 2 pipeline flex with shield devices failed to open in the middle section.A third pipeline flex with shield was successfully deployed but the patient experienced vessel occlusion immediately after implantation.The devices were prepared according to the instructions for use (ifu).The first pipeline flex with shield (model: ped2-500-20) was positioned and started to open the distal part on m1.However, the portion covered by the fins opened partially, and the proximal portion soon after did not open, and the remainder of the flow diverter until close to the repositioning mark opened normally.Recapping maneuvers were performed, dragging to the aci, but none of the maneuvers changed the flow diverter's non-opening.Thus, the entire system was removed and a new pipeline flex with shield (ped2-500-18) was prepared as indicated by ifu.It was positioned and started to open the distal part on m1.However, as the same of the last one, the portion covered by the fins opened partially, and the proximal portion soon after did not open, and the remainder of the flow diverter until close to the repositioning mark opened normally.Recapping maneuvers were performed, dragging to the aci, but none of the maneuvers changed the pipeline non-opening.Thus, the entire system was removed.It was noted the failed pipelines were not positioned in a vessel bend.The pipeline was more than 50% deployed when the failure to open was observed.The pipelines were resheathed 2 or less times.No other steps or devices were tried to open the pipelines.A new pipeline flex with shield (ped2-450-18) was prepared as indicated by ifu.This time it was positioned and deployed effectively.However, moments after implantation, the patient had an arterial occlusion.The physician had to perform an aspiration to restore blood flow.The patient was in serious condition, and remained so at time of the report.The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of the left internal carotid artery (ica).The aneurysm max diameter was 5mm and the neck diameter was 4mm.Dual antiplatelet treatment (dapt) was administered but pru level was unknown.Vessel tortuosity was moderate.

• 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
• MDR Report Key: 12722686
• MDR Text Key: 282111840
• Report Number: 2029214-2021-01366
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: PED2-450-18
• Device Catalogue Number: PED2-450-18
• Device Lot Number: B178270
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 75