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

Model Number PED2-450-20

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline could not be delivered through the marksman, and the distal segment failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right posterior communicating (pcom) artery with a max diameter of 4 mm and a 3 mm neck diameter.It was noted the patient's vesseltortuosity was severe.Dual antiplatelet therapy (dapt) was administered: prasugrel.It was reported that the marksman microcatheter was positioned in sector m1/m2, and an attempt was made to deploy the pipeline.However, force was exerted, but it was not possible to advance the pipeline.The stent did not come out of the marksman, and the entire set was removed.It was also stated the distal segment of the pipeline failed to open.The stent was not positioned in a bend, less than 50% was deployed, and resheathing was performed less than three times.A replacement pipeline was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed satisfactory results.Ancillary devices include a cook 8fr, marksman, avigo guidewire.

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 that the pipeline got stuck and couldn't be released.It was unknown if there was any damage to the catheter or pipeline.

Manufacturer Narrative

The pipeline flex pusher was found protruding from within the marksman catheter hub for ~17.8cm.No damage was found with the marksman catheter hub.The marksman catheter was found stretched and separated on the pipeline flex pusher at ~130.3cm from the proximal end of the hub.The tubing material of the separated ends exhibited with stretching, necking and jagged edges with the inner braid exposed.The pipeline flex braid was found partially deployed from within the marksman distal tip.The pipeline flex braid distal end was found open, but damaged (frayed).The ptfe sleeves and tip coil were found in good condition.The pipeline flex embolization device was pushed out from within the phenom 27 catheter with resistance, causing the braid to fully deploy.The pipeline flex pusher, proximal bumper, resheathing pad and resheathing marker were found intact.The pipeline flex braid proximal end was found open, but damaged (frayed).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open¿ could not be confirmed, as the device has been fully deployed and re-sheathed.Possible causes for failure to open are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel bend, presence of other indwelling endovascular stents, or inappropriate anatomy.It is likely the damage found with the braid (fraying) and the patient¿s ¿severe¿ vessel tortuosity contributed to the event; however, the root cause could not be determined.Regarding the customer¿s report of ¿resistance/stuck during delivery¿ the issue was confirmed.From the damages seen with the marksman catheter (stretch, separation); it appears there was high force used.The broken ends of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It is likely these damages occurred when the customer attempted to advance and/or retrieve the pipeline flex through the marksman catheter against resistance subsequently causing the catheter to become separated.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to failure to maintain a continuous flush or pipeline is pulled back/torqued during delivery.It is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the resistance; however, the root cause for the reported resistance could not be determined.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 W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10661585
• MDR Text Key: 213045976
• Report Number: 2029214-2020-01015
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 12/21/2020

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: 03/23/2023
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: A996944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 12/07/2020
• Supplement Dates FDA Received: 10/23/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 65