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

Model Number PED-500-18

Device Problems Retraction Problem (1536); Activation Failure (3270)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has been returned to medtronic.Evaluation is currently in progress.A follow-up mdr will be submitted when the investigation is complete.Linked mdr's 2029214-2017-01032, 2029214-2017-01033, 2029214-2017-01034.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 regarding a pipeline did not fully open during the treatment of a patient's aneurysm located at paraophthalmic segment of the internal carotid artery.This patient has normal vessel tortuosity.It was reported the device was prepared following the instruction for use.Continuous heparinized saline flush was used via the delivery system.When the physician started to deploy the pipeline, the distal end of the device did not fully open.After manipulating the pipeline flex delivery system, the physician attempted to deploy this pipeline at the vertical segment of the artery between the terminus and ophthalmic level.The device would not open.This device was removed from the patient.A new device was used.No report of injury.The removed pipeline flex was unsheathed at the back table.The pipeline opened when 3/4 of it was pushed out of the microcatheter.The distal end of the pipeline appeared frayed.

Manufacturer Narrative

Device evaluation the pipeline flex device was received for evaluation and the clinical observation could not be confirmed.As received, the pipeline braid was fully opened with slight fraying at both ends of the device.The pushwire was bent at 2.0cm to 8.0cm from the distal end.No other abnormalities were observed.The likely cause of the customer experience could not be determined, however, placing the pipeline braid at a vessel bend could have been a factor contributed to the reported experience.If information is provided in the future, a supplemental report will be issued.

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: 6863610
• MDR Text Key: 86135391
• Report Number: 2029214-2017-01033
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/08/2018
• Device Model Number: PED-500-18
• Device Lot Number: A055474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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
• Patient Age: 25 YR