MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-400-14

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information regarding an incident involving one of its manufactured products.Treatment of an unruptured saccular aneurysm measuring 4mm x 3mm located in the ophthalmic segment of the right ica (internal carotid artery).During the procedure, it was reported the distal segment of the pipeline flex was slow to open and numerous attempts were made to resheath the device but without success as the device was unresponsive.After a slight pull-back of system, the energy released and the pipeline flex opened.Further deployment was uneventful.Upon inspection of marksman, after the procedure, an unusual pattern was noticed.The flex was implanted.Post procedural angiogram showed an eclipse.The patient was on dual antiplatelet therapy and the anatomy was severe in tortuosity.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device will not be returned for evaluation as it was implanted in the patient.The lot history record review of the reported lot number showed no discrepancies that might have contributed to the reported experience.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4571147
• MDR Text Key: 5472021
• Report Number: 2029214-2015-00229
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2015

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: 12/19/2017
• Device Model Number: PED-400-14
• Device Lot Number: A053029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2014
• 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: 81 YR