MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number	FA-55150-1030
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that two pipeline's failed to open and a marksman catheter encountered catheter kickback.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the c7 with a max diameter of 4 mm and a 3.58 mm neck diameter.Landing zone: distal: 3.6 mm and proximal 5.03 mm.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet treatment was administered.The angiographic result post procedure showed the blood vessels unobstructed, but the distal end of the pipeline has not opened at all.It was reported that during the tae (transcatheter arterial embolization) procedure, the doctor used ped2-500-20 for deployment.The release started from the m1 location of the blood vessels.Upon fluoroscopic examination, it was observed that the distal end did not open.After a brief waiting period with no change, the doctor decided to retract the pipeline into the catheter and repeat the pr procedure.During the second attempt to release the pipeline, there was an opening in the middle segment, but the distal end remained unopened.The doctor then pulled the pipeline back to the t-zone to attempt to open the distal end.However, due to the excessive curvature of the blood vessels, a significant counterforce occurred during the pullback, causing the catheter to drop at the bend in the vessel.The doctor attempted to push the pipeline up for release, but it did not open.A second attempt to pull down yielded the same result.Subsequently, the doctor tried changing the microcatheter and repeated the steps for ped release, but the situation did not improve.Finally, a ped2-475-20 (lot: b591801) was used to complete the procedure.However, due to the patient's excessively curved blood vessels, the front end of this pipeline did not fully deploy either.It was reported the pipeline failed to open both of distal end.The pipeline was placed in a distal bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to two times.The pipeline was removed from the patient by resheathing and removing with the microcatheter.There were no additional steps or other devices required to open the pipeline.The pipeline was not used for an indication that is off-label.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a shuttle 8f sheath, phenom 27 guide catheter, phenom plus guide catheter, marksman microcatheter, transcend 0.014 guide wire and asahi 0.014 guidewire.Additional information received that the cause of the failure to open was determined.There were not multiple pipeline devices being used when movement occurred.The pipeline was not implanted at the intended location, the release had not been completed yet.The device did not jump during deployment.The marksman catheter used with the pipeline when it encountered the force that caused it to drop into the bend in the blood vessel.During the pullback, both the pipeline and marksman were simultaneously pulled, intending to position them at the designated implantation site.The lot # of the marksman catheter was fa-55150-1030; lot: 227593964.

• Brand Name: MARKSMAN
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19725821
• Report Number: 2029214-2024-01219
• Device Sequence Number: 20884666
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/11/2024

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 Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 227593964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/11/2024
• Date Device Manufactured: 10/24/2023
• 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 Sex: Female