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

Model Number PED-475-14

Device Problems Physical Resistance (2578); Detachment of Device or Device Component (2907)

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

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

Based on the return of the device, the clinical observation of pushwire detachment was confirmed.As received, the pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The outer diameter of the re-sheathing pad was measured and found to be within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was noted to be bent at 47.0 cm and 89.0 cm from the proximal end.Additional analysis of the surfaces of the detached pushwire is underway.A supplemental report will be submitted once the analysis results are available.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 during an attempt to deploy a second pipeline flex to treat an unruptured and fusiform left paraophthalmic internal carotid artery aneurysm, a moderate amount of friction was noted in the middle segment during device advancement.According to the physician the pipeline was, "observed to look like a champagne glass." to troubleshoot, the microcatheter was brought to the inner curve to continue the pipeline flex deployment.At this time, the hypo tube of the pushwire broke proximal to resheathing pad.The segment of the pushwire was retrieved with a gooseneck snare without incident and the procedure was ended.Treatment is planned for the future.There were no patient complications resulting from this event.Vessel tortuosity was moderate.(reference mdr 2029214-2016-00768 for the first pipeline used in the procedure.).

Manufacturer Narrative

The surfaces of the detached pushwire were sent for sem (scanning electron microscope) and eds (energy dispersive spectroscopy) analyses.The analyses confirmed presence of soldering material.The lot history record of the reported lot number was reviewed and no quality issues were identified that would have contributed to this event.Damages noted on the returned device suggest the detachment occurred due to tensile failure.This type of damage has been seen in cases with significant vessel tortuosity.In this case, a moderate amount of friction and tortuosity were noted.

Manufacturer Narrative

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.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5925162
• MDR Text Key: 53834608
• Report Number: 2029214-2016-00769
• 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: 09/15/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2018
• Device Model Number: PED-475-14
• Device Lot Number: A072944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided; 09/15/2016
• Supplement Dates FDA Received: 09/30/2016; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR