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

Model Number PED3-027-400-25

Device Problems Positioning Failure (1158); Activation Failure (3270)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a pipeline vantage that was difficult to deploy and failed to open at the proximal end.The patient was undergoing a procedure for flow diversion treatment of 2 unruptured internal carotid artery aneurysms.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was difficult to deploy and open in the first curve and the physician had to recapture several time but the distal end finally opened but the proximal end did not open.More than 50% of the pipeline was deployed when the failure to open occurred.It was noted the pipeline was not positioned in a vessel bend.The pipeline was resheathed more than 2 times.No other steps or devices were required to open the pipeline.It was resheathed and removed from the patient with the microcatheter.The pipeline was replaced to complete the procedure.There was no harm or injury to the patient.Post-procedure angiography showed ok results with the replacement pipeline deployed.

Manufacturer Narrative

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

• Brand Name: PIPELINE VANTAGE WITH 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: 14111718
• MDR Text Key: 290531818
• Report Number: 2029214-2022-00631
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-400-25
• Device Catalogue Number: PED3-027-400-25
• Device Lot Number: B224036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• 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: 55 YR
• Patient Sex: Female