MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-18

Device Problems Positioning Failure (1158); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Medtronic received information that a pipeline stent had difficult placement and after pushing the catheter to go upper again, after pushing out the stent, it was found that the tip end of the stent was obviously worn and bifurcated, and then the stent was replaced.After pushing the marksman to go upper, repeatedly pushed and pulled the stent, and found that the effect of pushing and pulling the microcatheter was not good.After withdrawing from the body, it was found that the tip of the microcatheter was kinked like an accordion.The patient was being treated for an unruptured saccular aneurysm in the cavernous sinus segment.The max diameter was 8 mm and the neck diameter was 6 mm.The distal landing zine was 4.0 mm and the proximal landing zone was 4.1 mm.Vessel tortuosity was moderate.It was indicated the devices were prepared as according to the instruction for use (ifu).The catheter was flushed as per ifu.No symptoms were reported.Additional information received reported that only one pipeline was used for the operation.The patient's blood vessel was tortuous, and the microcatheterwas rubbed and recovered 2-3 times during the process of passing through the blood vessel.After delivering the pipeline to the reserved site, the stent could not be opened.The device did not jump during deployment.During the deployment process, the tip of the catheter was expected to be withdrawn, but the tip of the catheter was stuck with the stent and it could not be moved.

Manufacturer Narrative

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

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 failed to open at the distal end.It was noted there was significant resistance during delivery of the pipeline due to the patient's vessel tortuosity.The pipeline was not positioned in a vessel bend but it was noted that the proximal end of the patient vessel was extremely tortuous.The device was resheathed and redeployed but still did not open satisfactorily.No other devices or maneuvers were tried to open the pipeline.No damage was observed to the pipeline.

Manufacturer Narrative

H3: the pipeline flex embolization device and marksman catheter were returned for analysis.No bends or kinks were found with the pipeline flex pusher; however, the pusher shrink tubing was found damaged at ~149.5cm from the proximal end.Approximately 34.0cm of the marksman catheter distal segment was found separated and stuck on the pipeline flex pusher at ~171.0cm from the pusher¿s proximal end.The marksman catheter distal segment was found accordioned at the separated end.The pipeline flex pusher tip coil was found extending out from within the marksman distal tip.No damage was found with the marksman distal tip.The marksman catheter was dissected (cut) and the pipeline flex pusher was found detached at the distal hypotube weld (solder joint) within the marksman catheter.The pipeline flex braid proximal end was found open; however, the distal end was found partially closed (tapered).Both ends of the pipeline flex braid were found damaged (frayed).There was some damage to the braid middle segment during removal from within the marksman catheter.The pipeline flex pusher sleeves and tip coil were found damaged.The proximal end of the marksman catheter was returned.The catheter hub was found to be in good condition.No bends or kinks were found with the marksman catheter proximal segment.The marksman catheter was found separated at ~130.7cm from the proximal end of the hub.The marksman catheter proximal segment was found accordioned at the separated end.The detached pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).Based on the device analysis and reported information, the customer¿s ¿difficult placement/positioning¿, ¿pipeline damaged¿, ¿catheter accordion¿, ¿resistance/stuck during delivery¿, and ¿failure/incomplete open distal¿ reports were confirmed.The investigation determined that the resistance event was similar to those already investigated, and another investigation is not necessary.Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies.In this event, it is likely the patient¿s ¿extreme¿ vessel tortuosity contributed to these events.From the damages seen with the marksman catheter (accordioned/separation) and the pipeline flex pusher (pusher shrink tubing damaged/separation) it appears force was used.Regarding the solder joint separation issue, this event is similar to events that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, solder joint separation can occur due to excessive force or inadequate solder/tinning.As the analysis showed the 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 was performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to a specification that led to the resistance and detachment issues.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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

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: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12990383
• MDR Text Key: 289666669
• Report Number: 2029214-2021-01602
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-18
• Device Catalogue Number: PED-475-18
• Device Lot Number: B249597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 55 KG