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

Model Number PED-450-25

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the flow diverter distal pushwire tip was stuck at the microcatheter hub.The flow diverter was removed, examined, rinsed, and attempted to push the flow diverted distal tip in again two more times.On the third try, the tip passed the hub and entered the microcatheter approximately 1-2 inches and could not be pushed or pulled anymore.The flow diverter was removed, and the distal tip was found kinked and broken.A new flow diverter was used to complete the procedure.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of a large unruptured saccular aneurysm measuring 28mm x 7mm located in the cavernous segment of the right internal carotid artery (ica).The distal and proximal landing zone was 3.56mm x 4.60mm.The vasculature was normal in tortuosity.It was unknown if the patient was on dual antiplatelet therapy.There are no images for review.Post procedural angiography showed the aneurysm was embolized.

Manufacturer Narrative

Change to b5.Desc evt problem the original report received stated that the pipeline pushwire distal tip was kinked and broken.After follow-up was sent for clarification, it was discovered that the distal pushwire was kinked/bent and ¿not¿ broken as initially reported.The malfunction is not reportable.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

It was reported that the distal pushwire was kinked/bent and ¿not¿ broken as initially reported.

Manufacturer Narrative

When compared to the drawing the distal and proximal dps restraints were found to be intact.The resheathing pad was found intact.The hypotube was found stretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal/distal bumpers.The dps sleeves were found damaged.The tip coil was found stretched.The distal and middle braid did not fully open and found damaged.The proximal braid was found frayed.The pipeline flex could not be used for resistance testing as the device was already deployed.No other anomalies were observed.Based on the analysis findings, the customer report of ¿stuck in catheter hub¿ could not be confirmed and the cause could not be determined.Possible causes are introducer sheath not securely seated inside the hub, tip coil/delivery system damaged, ped stuck in sheath, user does not maintain continuous flush, user pulls back on/torques wire during insertion rhv overtightened/not tightened enough.As the y-valve and marksman micro catheter used in the event was not returned, any contribution of the y-valve and micro catheter towards the ¿stuck in catheter hub¿ could not be confirmed.The customer report of ¿pusher damaged¿ was confirmed.From the damages seen on pipeline pusher hypotube (stretched), tip coil (stretched) and braid (frayed/damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the reported resistance.Possible contributor towards the failure is lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.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: 10222270
• MDR Text Key: 197931005
• Report Number: 2029214-2020-00645
• 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,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A997340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 09/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR