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

Model Number PED2-375-16

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

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline was unable to be resheath and did not open fully in the middle section.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right internal carotid-posterior carotid (i c-pc).The max diameter was 6mm, and the neck diameter was 3mm.The patient's vessel tortuosity was moderate.The landing zone was 3.6mm distal and 3.8mm proximal.The access vessel was the ic, which was maximum ~3.8mm.It was reported that product deployment was initiated from a suitable position; the deployed tip was confirmed to be in a good position.When attempting to resheath and move to the distal region that it should be deployed, resistance was felt in the resheath.Resheath was attempted twice, but it did not improve.Therefore, the tip was moved without being completely stored, and deployment was initiated from an appropriate position.There was an insufficient portion when about half of it was deployed.When it was resheathed, resheathing became difficult from the already deployed position.During that time, the distal end moved towards the front, so it was determined that re-positioning was difficult, and it was removed.The sleeve was removed during the removal state, and the tip was deployed. when deployed outside the patient's body, the delivery pusher was pushed distally longer than usual, and it is identified that the positional relationship with the pipeline was strange. the devices were replaced, and the patient did not experience any health damage.Postoperative findings related to blood flow contrast showed no issues.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a phenom 27 microcatheter.

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 there was no damage to the pushwire or catheter observed.The pipeline was located in a tortuosity from the middle cerebral artery (mca) to the internal carotid (ic) top.Additional step attempted to open the pipeline include doing the sheath, resheath and the expansion position was adjusted.The cause was not determined.

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: product analysis: as found condition: the pushwire and phenom 27 were returned for analysis inside of a sealed bio-hazard bag and a shipping box.There was no pipeline flex shield braid returned with the devices.Damage location details: 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 appeared to be stretched with the ptfe shrink tubing still intact.No bend was found on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad 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 11.5cm from the distal tip.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Conclusion: based on the returned devices, the customer complaint of "failure to open at the middle section" was not confirmed as the pushwire was returned without the braid.The cause could not be determined.However, the customer report of "failure to resheath" and "catheter resistance" were confirmed as the returned pushwire and catheter were found damaged.From the damages seen on the catheter (accordioning) and hypotube (stretching); it appears there was high force used.It is possibly these damages occurred when the customer attempted to retrieve the pipeline flex shield through the catheter against the resistance.However, the cause of resistance could not be determined.Possible causes includes the use of damaged device, vessel tortuosity and lack of continuous flush during delivery.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: 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: 15798497
• MDR Text Key: 307804817
• Report Number: 2029214-2022-01935
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-375-16
• Device Catalogue Number: PED2-375-16
• Device Lot Number: B318541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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