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

Model Number PED-500-25

Device Problem Break (1069)

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

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during embolization treatment of carotid artery, while pipeline flex device was advanced in the medtronic catheter the pipeline pushwire broke.It was reported that the physician felt strong resistance while delivering the pipeline through microcatheter after flushing as according to the ifu.However, the physician somehow kept delivering, deployed the flow diverter and started resheathing, but resheathing was not very smooth.The flow diverter was deployed and opened at the desired position.However, while advancing the microcatheter in order to retrieve the pipeline delivery pushwire, the catheter got caught on the delivery pusher (probably the sleeve of the system).The physician kept retrieving the pusher into the catheter but still the pushwire caught on the catheter.The physician successfully retrieved the pushwire into the catheter by pushing the pusher little bit.However, upon completing retrieving, snapping noise was heard.Nothing was left inside the patient¿s body.The vessel was slightly severe and slightly large in diameter.There were no reports of patient injury in association with this event.

Manufacturer Narrative

The pipeline flex pushwire was returned for evaluation outside of the catheter.The pipeline flex braid was not returned.The reason for not returning was not provided.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were observed on the pushwire near the proximal end.The pushwire appeared to be intact.No separation was found with the returned pushwire.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and the marker band were examined, and no damages were found.The catheter body appeared to be accordioned at the distal tip.No flash or voids molded were observed in the hub.The catheter was flush with water and found to be patent.The catheter was then tested by running an in-house mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the accordioned locations.No other anomalies were observed.Based on the analysis findings, the reports of pushwire separation issue, the customer complaint could not be confirmed as the returned pushwire appeared to be intact.No separation was found on the pushwire.However, the event cause could not be determined.The returned pipeline flex pushwire and the catheter found to be damaged.From the damages seen on the catheter body (accordioning), proximal wire (kinking/bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the catheter against resistance.It's possible that the ¿severe vessel tortuosity¿ and ¿lack of continuous flush with heparinized saline¿ may have contributed the resistance during delivery.The customer reported that the devices were prepared per the ifu.However, the customer did not report whether a continuous flush with heparinized saline was maintained during delivery.In addition, the patient's vessel tortuosity was severe.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8150716
• MDR Text Key: 129912914
• Report Number: 2029214-2018-01048
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: PED-500-25
• Device Lot Number: A643198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1