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

Model Number PED-500-25

Device Problems Unintended Movement (3026); Activation Failure (3270)

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

Event Date 08/25/2020

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 one pipeline failed to open, and both pipelines had difficult placement due to system tension resulting in device replacement.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left posterior communicating (pcom) artery with a max diameter of 14mm and a 9.4mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered and the pru level was normal.It was reported that the surgeon successfully delivered the phenom 27 microcatheter (pli-30) to the middle cerebral artery m2.The pipeline (pli-10) was delivered in place, and deployed 8mm, but the stent tip did not open.The surgeon tried multiple times, but the tip still did not open.The phenom 27 and pipeline were pulled to the thicker side of the internal carotid artery, and another attempt was made to open the device.System tension caused the distal part of the entire system to fall into the aneurysm, and it could not be put in place for deployment again.The surgeon retrieved the stent and withdrew the stent and microcatheter.A new phenom27 (pli-40) and pipeline (pli-20) were then placed in the middle cerebral artery (mca).The tip of the pipeline opened smoothly, and the surgeon decided to drag the stent to the predetermined distal landing position.The system tension caused the distal part of the entire system to fall into the aneurysm again.Again, the microcatheter and pipeline were removed from the patient.A marksman microcatheter and a third pipeline were then used, and the deployment was smooth.Adherence was good, and post-procedure angiographic results showed good results and blood retention.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.It was also reported that in the two systems, the surgeon tried to push out the stent in vitro, and it was found the guidewire was pushed out but the implantation was not pushed out at the distal end.It was stated it was possible the guidewire was broken and the implantation was stuck in the phenom27.However, this was not confirmed, and conflicts the previously reported information.Ancillary devices include a navien catheter.

Event Description

Additional information received reported that the distal section of the pipeline did not open.The device had not been placed in a vessel bend at the time, and there was not any friction/difficulty during delivery or positioning.The device did not jump during deployment, nor was the tip of the catheter moved during deployment.No additional steps were attempted to open the pipeline.

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.

Manufacturer Narrative

H3: two pipeline flex (model: ped-500-25 lot: b027931) (model: ped-500-30, lot: b013893) and two phenom-27 micro catheters (model: fg 15150-0615-1s, lot: nv19-035) were returned for analysis.It was not possible to determine which device belong to which product line item (pli).(first pipeline flex and phenom-27) the phenom-27 micro catheter total length was measured to be ~158.7cm, the usable length was measured to be ~152.1cm and the distal single coil length was found to be 14.8cm, which is within specification (specification: total (ref) = 156.5cm, usable = 150cm ± 5cm, distal single coil = 15cm ± 2cm).No flash or voids molded were found within the catheter hub, however an occlusion was found within the hub.No damages or anomalies were found with the hub.The phenom-027 micro catheter body was found kinked at ~44.4cm and ~134.2cm from the proximal end and found kinked at ~2.0cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The micro catheter was flushed, and water did not exit the distal end.An in-house 0.0260¿ mandrel was inserted into the hub and became stuck.The mandrel was inserted into the distal end and became stuck at ~2.0cm.The occlusion could not be pushed out.The phenom-27 catheter was destroyed to remove the braid/distal wire.No damages were found with the proximal pipeline flex pusher.The hypotube was found stretched.The distal wire was separated from the hypotube proximal to the wire weld.The coil tip and dps sleeves were found damaged, caused at least in part during extraction from the phenom-27 micro catheter.The distal wire could not be found.One end of the braid was found slightly tapered, frayed and damaged.The other end fully opened and found frayed.The hypotube was sent out for eds testing.No other anomalies were observed.Based on the analysis findings, the customer report of ¿movement during deployment¿ could not be confirmed as this complaint cannot be confirmed based on device evaluation and the customer did not send any video/pictures of the event.Possible causes of failure include vasospasm, patient vessel tortuosity, high delivery force, catheter kickback, insufficient distal anchoring of braid, or incorrect braid size.The customer report of ¿failure/incomplete to open¿ was confirmed.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.Customer reported the device was not placed in vessel bend, there was not any friction/difficulty during delivery or positioning, the device did not jump during deployment, nor was the tip of the catheter moved during deployment.The elemental analysis of the hypotube hole showed presence of tin (sn).Separation can occur if excessive force is used exceeding the tensile strength of the material.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).From the damages seen on the catheter body (kinking), distal wire (separation from hypotube) and braid (frayed/damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the marksman catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.(second pipeline flex and phenom-27) the phenom-27 micro catheter total length was measured to be ~158.4cm, the usable length was measured to be ~151.9cm and the distal single coil length was found to be 15.0cm, which is within specification (specification: total (ref) = 156.5cm, usable = 150cm ± 5cm, distal single coil = 15cm ± 2cm).No flash or voids molded were found within the catheter hub, however an occlusion was found within the hub.No damages or anomalies were found with the hub.The phenom-027 micro catheter body was found kinked at ~15.9cm from the proximal end and found kinked at ~0.9cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The micro catheter was flushed, and water did not exit the distal end.An in-house 0.0260¿ mandrel was inserted into the hub and became stuck.Blood and particulates were found on the tip of the mandrel when retracted back out.The mandrel was inserted into the distal end and became stuck at ~0.9cm.The occlusion could not be pushed out.The phenom-27 catheter was destroyed to remove the braid/distal wire.The pipeline flex pusher was found bent at ~151.8cm from the proximal end.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 bumper.The distal wire was found broken between the re-sheathing pad and the dps sleeves.The distal segment was found within second phenom-27 micro catheter.The coil tip and dps sleeves were found damaged, caused at least in part during extraction from the phenom-27 micro catheter.Both ends of the braid were found tapered, frayed and damaged.The broken end was sent out for sem analysis.Sem summary: the wire failed via torsional overload.Based on the analysis findings, the customer report of ¿movement during deployment¿ could not be confirmed as this complaint cannot be confirmed based on device evaluation and the customer did not send any video/pictures of the event.Possible causes of failure include vasospasm, patient vessel tortuosity, high delivery force, catheter kickback, insufficient distal anchoring of braid, or incorrect braid size.The customer report of ¿failure/incomplete to open¿ was confirmed.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.Customer reported the device was not placed in vessel bend, there was not any friction/difficulty during delivery or positioning, the device did not jump during deployment, nor was the tip of the catheter moved during deployment.From the damages seen on the catheter body (kinking), distal wire (break) and braid (frayed/damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the marksman catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.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: 10458051
• MDR Text Key: 204928556
• Report Number: 2029214-2020-00852
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019751
• UDI-Public: 00847536019751
• 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: 12/06/2020

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: 05/20/2023
• Device Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: B027931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 11/28/2020
• Supplement Dates FDA Received: 09/15/2020; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR