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

Model Number PED-425-20

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex braid remains implanted in the patient; the pipeline flex delivery wire (pushwire) was not returned to the manufacturer, therefore, device evaluation cannot be performed.Photos of broken distal segment was received.Based on the photos provided by the reporter, the reported pushwire break at the distal segment was confirmed.As the actual device cannot be evaluated, the cause of the clinical experience could not be determined.It is possible that the patient's "severe vessel tortuosity" might have contributed to the "severe friction" reported during retrieval of the pushwire.The continuation of pushwire retrieval despite of the "severe friction" could have subsequently causing the pushwire to detach at the proximal wire weld.Review of lot history record showed the finished device met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damages and irregularities during manufacturing.Per pipeline flex embolization device instruction for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the distal segment broke off the pushwire of a pipeline flex device inside the patient after the braid was deployed.The pipeline flex device was used for flow diversion treatment of this patient's saccular aneurysm at the ophthalmic segment of left internal carotid artery.The aneurysm had max diameter of 7 mm and neck width of 6 mm.The landing zone artery measured 3.75 mm distally and 4.25 proximally.Vessel tortuosity was described as severe.It was reported the device was prepared as indicated in the ifu.A non-medtronic microcatheter was used to deliver the pipeline flex device.The braid was deployed and implanted as anticipated.After the deployment, there was severe friction during retrieval of the pushwire.The distal segment of the push wire broke off at the proximal bumper.The broken segment was removed from the patient by using a guidewire.There was no injury to the patient.

Manufacturer Narrative

Device evaluation the pushwire of the reported pipeline flex embolization system was returned for analysis.As received, the pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched, and a bend was found at 27.5cm from the proximal end of the pushwire.Based on the product analysis, the report of ¿pushwire detach at hypotube proximal to the wire weld¿ was confirmed.A review of the manufacturing process did not uncover any deficiencies.The review of lot history records shows that the finished device met all manufacturing requirements and specifications during final assembly and quality inspection.Therefore manufacturing has been ruled out as a potential cause.The damages exhibited on the returned pipeline flex pushwire: proximal wire (bending) and hypotube (stretching), it appears there was excessive forced used (pushing and pulling).The patient's ¿severe vessel tortuosity¿ might have contributed to the severe resistance during retrieval; subsequently causing the pipeline flex pushwire to detach at the hypotube proximal to the wire weld.The manufacturer's instruction for use states, "caution: 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.If the delivery wire cannot be retracted into the micro catheter, carefully remove the delivery wire and micro catheter simultaneously.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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 ; 9496801221
• MDR Report Key: 7004340
• MDR Text Key: 92197979
• Report Number: 2029214-2017-01230
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/25/2018

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: Health Professional
• Device Expiration Date: 06/18/2018
• Device Model Number: PED-425-20
• Device Lot Number: A123393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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: 42 YR
• Patient Weight: 85