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

Model Number	PED-425-30
Medical Device Problem Codes	Unintended Movement (3026); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline failed to open distally and the marksman catheter was damaged.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ophthalmic artery.The max diameter was 15mm, and the neck diameter was 9mm.The patient's vessel tortuosity was moderate.The landing zone was 3.9mm distal and 4.25mm proximal.The access vessel was the femoral artery. dual antiplatelet treatment was administered.It was reported that the head segment of the pipeline could not be opened.Repeated adjustments and trouble-shooting did not result the issue.The pipeline fell into the tumor.It was noticed that the head segment of the marksman was severely damaged. the devices were replaced, and the patient did not experience any injury or complications.Angiographic results post procedure were normal.The devices were prepared and flushed according to the instructions for use (ifu).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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 or Problem Description
Additional information received indicating there was friction during the deployment process of the tip end after repeated attempts.The tip of the catheter moved during deployment.The distal end was deployed, the distance was short, and the tip end deployment point was curved and then adjusted to a straight position.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83360); as found condition: the pipeline flex braid was returned for analysis within a shipping box and within a plastic bio-pouch.The pipeline flex pusher and the marksman catheter were returned within a separate shipping box and within a plastic bio-pouch.Visual inspection/damage location details: the pipeline flex braid was returned partially deployed out from an unknown sheath¿s distal tip.The braid was removed from within the sheath distal tip.The pipeline flex braid ends were found fully open.The braid proximal end was found in good condition; however, the distal end was found damaged (frayed).The pipeline flex pusher was found extending out from within the marksman catheter hub for ~49.5cm.No damages were found with the marksman catheter hub.No bends or kinks were found with the catheter body.The marksman distal tip was found in good condition.The pipeline flex pusher was pushed out from within the marksman catheter without issue.No bends or kinks were found with the pusher.The resheathing pad, sleeves and tip coil were found in good condition.Testing/analysis: the marksman catheter total length was measured to be ~158.6cm and the useable length was measured to be ~151.0cm which is within specification (specification: 150cm ± 3cm).Conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete open distal¿ report could not be confirmed as the device has been fully deployed and re-sheathed.However, it is likely the damage found with the pipeline flex braid and the patient¿s ¿moderate¿ vessel tortuosity contributed to the event.The cause for the damage to the braid could not be determined.Regarding the customer¿s ¿movement during deployment¿ report the issue could not be confirmed.It is possible the patient¿s ¿moderate¿ vessel tortuosity contributed to the event contributed to the event.Regarding the customer¿s ¿catheter kink/damage¿ report the issue could not be confirmed as no damages were found with the returned marksman catheter.H6.Coding updated based on analysis results.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
• Common Device Name: 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: 13289761
• Report Number: 2029214-2022-00063
• Device Sequence Number: 4409154
• Product Code: OUT
• UDI-Device Identifier: 00847536016262
• UDI-Public: 00847536016262
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: PED-425-30
• Device Catalogue Number: PED-425-30
• Device Lot Number: B174946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 01/24/2022; 03/29/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 02/20/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 65 KG