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

Model Number PED-500-30

Device Problems Break (1069); Physical Resistance (2578)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device did not match initial reported condition.Additional information has been requested based upon the condition of the returned device, however no response has been received.Further investigation is in progress.When completed, a supplemental report will be submitted.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 during the initial introduction of the pipeline flex, it became stuck (locked up) in the middle segment of a microcatheter during a flow diversion procedure.The devices were used for the treatment of an aneurysm located at the patient's internal carotid artery.It was reported this pipeline flex was prepared according to the ifu.Continuous heparinized saline flush was used during the procedure.The physician also released the load in the system but could not resolve the issue.This pipeline and the microcatheter were withdrawn from the patient.There was no damage to the pushwire.New pipeline flex and catheter were used to complete the procedure for this patient.No injury was reported.The reported pipeline pushwire was received by the manufacturer not matching initial reported condition.The pushwire of the pipeline flex system was returned without the tip coil and distal protective sleeves segment.No information was available when the segment was detached from the pushwire.

Manufacturer Narrative

As received, the pipeline flex pushwire was observed sepa rated into two segments (distal and proximal).The separation was not originally reported.The pipeline braid was returned detached from the pushwire and found fully opened.The pipeline braid was found fraying at the both ends.Additionally, the distal segment of the pipeline flex pushwire including the tip coil and distal protective sleeves (dps) were missing.The pushwire bent at the proximal end.The distal section of the proximal segment of the pipeline flex pushwire was sent out for scanning electron microscopy (sem) analysis.Follow up has been done in regard to the missing distal segment; however, no responses have been received.Based on the sem analysis, the failure mechanism for the separation was wire failure via torsional overload failure.It is possible that the reported ¿resistance¿ may have contributed to damages observed on the pipeline flex; it appears excessive force was used (pushing and pulling).Per our instructions for use (ifu): ¿it is recommended to use a heparinized saline drip to continuously flush micro catheter during pipeline flex embolization device use.If high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously.Advancement of the pipeline flex embolization device against resistance may result in damage or patient injury.¿ no evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.All products are 100% inspected for damage and irregularities during manufacture.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: 6912632
• MDR Text Key: 89614730
• Report Number: 2029214-2017-01110
• 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
• Report Date: 11/10/2017

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: Physician
• Device Expiration Date: 01/24/2019
• Device Model Number: PED-500-30
• Device Lot Number: A216921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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