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

Model Number PED-350-20

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation.The reported event could not be confirmed event cause could not be conclusively determined from the provided information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pipeline flex device twisted during deployment.It was reported that multiple attempts were made to correct the issue, but this was not successful.The pipeline flex was then withdrawn from the microcatheter.When withdrawing the device, the pipeline flex deployed in the microcatheter hub.As a result, the microcatheter had to be removed from the patient.A new catheter and pipeline flex were used for the patient to complete the treatment.No injury reported.The patient was receiving flow diversion with the pipeline flex to treat an amorphous internal carotid artery (ica) aneurysm with maximum diameter of 30 mm and a neck diameter of 10 mm.The distal and proximal landing zones of the parent artery both measured 3.4 mm.This patient's vessel tortuosity was described as severe.

Manufacturer Narrative

This report was submitted with the date of report as the manufacture notified date.A correction is being filed to reflect the date of report as the date the initial report was submitted.If information is provided in the future, a supplemental report will be issued.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6865113
• MDR Text Key: 86139134
• Report Number: 2029214-2017-01035
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PED-350-20
• Device Lot Number: A111230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2015
• 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