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

Model Number PED2-400-18

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

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

Event Date 08/06/2020

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 pipeline failed to open and became stuck in the marksman microcatheter.The patient was undergoing surgery for treatment of a fusiform, ruptured aneurysm with a max diameter of 6mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was reported that the pipeline was being released into the right posterior communicating (pcom) artery, and when in the ophthalmic segment, an attempt was made to re-sheath because the stent did not open at that point.When trying to release the device again, the marksman catheter would not disengage or advance.The physician attempted to retract to release the device, but it was jammed.After several attempts, it was decided to advance the navien 058 catheter and recover the entire system.The removal of the system was effective.New devices were used to complete the procedure with no further issues.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 angiographic results looked normal.

Event Description

Additional information received reported that the middle section of the pipeline did not open.The device had been in the opthalmic segment when it did not open.

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.

Manufacturer Narrative

H3: the pipeline flex w/ shield pusher (model: ped2-400-18 lot: a999785) and marksman micro catheter (model: fa-55150-1030 lot: 218421786) were returned for analysis.No flash or voids molded were found within the catheter hub.Dried blood was found within the hub and the pipeline flex w/ shield pusher was extending out of the hub ~3.0cm.The marksman micro catheter total length was measured to be ~158.0cm and the usable length was measured to be ~150.4cm which is within specification (specification: total (reference) = 157cm ± 3cm, usable = 150cm ± 3cm).The marksman micro catheter body was found accordioned at ~117.0cm from the proximal end, and between ~30.2cm and ~24.7cm from the distal end.The micro catheter was flushed with water and a large amount of blood exited out the catheter tip.The pipeline flex w/ shield pusher was removed against high resistance.Dried and liquid blood exited along with the pusher.The device was flushed again until clear water exited out the distal end.A 0.026¿ mandrel was then used for resistance testing.The mandrel was inserted into the hub, through the catheter lumen and out the distal tip with no resistance encountered.The inner diameter was measured to be 0.0265¿ for both the distal and proximal ends, which is within specification (specification: 0.027¿ ± 0.001¿) and compatible for use with the pipeline flex w/ shield.No damages or irregularities were found with the pipeline flex pusher.The hypotube was found intact and unstretched.No damages or irregularities were found with the proximal bumper, resheathing pad, resheathing marker, distal wire, ptfe dps sleeves, distal marker, or tip coil.The pusher was inserted back within the marksman, and no resistance was encountered.No other anomalies were observed.Based on the analysis findings, the pipeline flex shield and marksman were confirmed to have ¿lockup/resistance at distal segment of catheter¿ and ¿catheter resistance¿ as the devices were returned with resistance between the pipeline flex w/ shield pusher and marksman catheter.It is likely the large amount of blood found within the catheter was the cause of the resistance found during analysis.No resistance was encountered after the blood was flushed out from the lumen.It is possible that a continuous flush was not administered during the procedure, causing the blood to reflux up and occluding the catheter.Other possible causes for resistance are patient vessel tortuosity or braid damaged.As the braid was not returned for analysis, any contribution of the braid towards the resistance could not be determined.Customer report patient vessel tortuosity as minimal and devices were prepared as per ifu.The marksman catheter were found accordioned.Possible causes are catheter entrapment, or the pipeline flex w/ shield was removed aggressively.The customer report of ¿failure/incomplete open at middle section (hourglass shape)¿ could not be confirmed as the braid was not returned for analysis.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.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: 10390402
• MDR Text Key: 202976941
• Report Number: 2029214-2020-00783
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2023
• Device Model Number: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: A999785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 55