MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-450-20

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline stent that did not open during a procedure with a and was observed to be damaged upon removal.The patient was being treated for an unruptured saccular aneurysm of an ophthalmic artery segment.The artery max diameter was 9.65mm and the neck diameter was 6.33mm vessel tortuosity was moderate.It was reported that all the devices used in the procedure were prepared and used according to the instructions for use (ifu).The pipeline did not open completely at the distal end during the procedure so the catheter and pipeline device were withdrawn form the patient's body together.It was then discovered that the pipeline was overlapped.The devices were replaced to complete the procedure.There was no harm or injury to the patient and post-procedure angio was normal.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Event Description

Additional information received reported the pipeline was inspected prior to preparation and it appeared normal.The pipeline had not been placed in a vessel bend when it failed to open.The doctor had tried to increase/decrease tension and pushed the catheter forward and backward in attempt to get the device to open.

Manufacturer Narrative

Product analysis #(b)(4):equipment used: video inspection system (m-77148), ruler (m-83360), 0.0260¿ mandrel, camera (panasonic lumix dmc-zs5) the pipeline flex (model: ped-450-20 lot: a875015) and microcatheter were returned for analysis within a shipping box; within their respective opened outer cartons; within individual sealed plastic biohazard pouches; within their respective opened inner pouches; and within their respective dispenser coil.The pipeline flex braid was returned already detached and within a syringe.The devices were decontaminated as per manufacturer protocol.The microcatheter measurements were all within specification and compatible for use with the pipeline flex.No flash or voids molded were found within the catheter hub.Dried saline was found within the hub.No damages or anomalies were found with the hub.The microcatheter body was found accordioned between ~29.2cm to ~23.1cm from the distal end.The microcatheter was found kinked at ~12.8cm and ~4.0cm from the distal end.No damages or irregularities were found with the distal tip and marker band.The microcatheter was flushed with water and water exited out from the catheter tip.The catheter was then tested by running an in-house 0.0260¿ mandrel through microcatheter.The mandrel passed through the catheter hub, catheter body and distal tip with no resistance encountered.When compared to the drawing, the pipeline flex distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube was found intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found intact.Both ends of the returned pipeline flex braid were found to be tapered with damages and fraying found on both ends.The middle braid was found to have creased.No other anomalies were observed.Based on the analysis findings, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.Possible causes for failure are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.The customer report of ¿failure/incomplete open distal (flex)¿ was confirmed as both ends of the braid failed to open.It is likely the failure to open is caused by the damages to the braid ends.Other possible causes for failure are patient vessel tortuosity, braid improperly sized to a natomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.The customer report of catheter kink was confirmed.Possible causes are patient vessel tortuosity, possible oversized od, guidewire or delivery system removed aggressively, incompatible devices, catheter entrapment, or user operational context if user advances or retrieves intraluminal device against resistance.From the damages seen on the braid (frayed/damaged) and catheter (accordion/kink); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the microcatheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.Per medtronic instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encou ntered.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 intralumenal 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.¿ medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10314697
• MDR Text Key: 202021390
• Report Number: 2029214-2020-00717
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• 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,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: A875015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Date Manufacturer Received: 08/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR