MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED3-021-350-25

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline failed to open in the middle section and experienced resistance in the phenom microcatheter.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the basilar artery.The max diameter was 14mm, and the neck diameter was 8mm.The patient's vessel tortuosity was severe.The landing zone was 2.8mm distal and 3.4mm proximal.The access vessel was vertebral, which was 3.4mm in diameter.It was reported that the device was parked distal to the aneurysm.Support was failing from the proximal end because of vessel tortuosity.The device initially opened but failed to take the shape at the neck of aneurysm.Also, it was observed that there was resistance in the distal part of the catheter while deploying the device and was falling in aneurysm while further deploying.While resheathing resistance was observed again.Two attempts were made and device was withdrawn as it failed to open.It was also observed that the proximal pusher wire was also kinked because of the resistance.The pipeline was not positioned in a bend and less than 50% had been deployed when it failed to open.The pipeline had been resheathed 2 or less times, and no other steps were taken to open the device.The procedure was completed with another device, and the patient did not experience any injury or complications.Angiographic results post procedure showed reduced flow in the aneurysm.The devices were prepared and flushed according to the instructions for use (ifu).

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

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 device did not jump during deployment.

Manufacturer Narrative

H3: the pipeline vantage and phenom 21 catheter were returned for analysis.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the braid were found opened and frayed.The middle section of the braid was found opened and no damage.Bends found at 23.0cm to 30.0cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, advanced resheathing mechanism or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 4.0cm to 16.0cm from the distal tip.No flash or voids molded were observed in the hub.No other anomalies were observed.The total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.018¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Based on the returned devices, the customer complaint of "failure to open at the middle section" was not confirmed as the middle section of the braid were found opened with no damage.The distal and proximal end of the braid were also found opened and frayed.The damage to the ends of the braid is likely the results of the physician re-sheathing the device more than recommended two times.However, the customer complaint of "resistance during delivery", and "catheter resistance" were confirmed.From the damages seen on the catheter (accordioning), pushwire (bending) and pipeline braid (fraying); it appears there was high force used.It is likely these damages occurred when the customer attempted to retrieve the pipeline vantage through the catheter against the resistance.It is possible that the severe vessel tortuosity may have contributed to the failure to open and resistance during delivery.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resis tance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis." 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 VANTAGE WITH SHIELD TECHNOLOGY
• 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: 15150195
• MDR Text Key: 304897524
• Report Number: 2029214-2022-01291
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 12/16/2022

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: 08/10/2024
• Device Model Number: PED3-021-350-25
• Device Catalogue Number: PED3-021-350-25
• Device Lot Number: B248203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/30/2022; 12/07/2022
• Supplement Dates FDA Received: 08/30/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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 Sex: Female