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

Model Number	FG13150-0615-2S
Medical Device Problem Codes	Difficult to Advance (2920); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a phenom encountered movement during placement of the pipeline (difficult placement/positioning) the reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured right mca aneurysm with a blister morphology.Aneurysm dimensions: max and neck diameter n/a.Landing zone (artery size): distal 2.59 mm and proximal 2.74 mm.The patient¿s vessel tortuosity was minimal.The physician was treating a ruptured right mca bifurcation blister aneurysm via this pipeline vantage fd.They used cerebase da long sheath <(>&<)> phenom plus dac as access products.Then they took phenom-21 microcatheter over hybrid-12/14 guidewire to place it distally in right inferior mca branch.After placing phenom-21, they started pushing this pipeline vantage fd.When this fd started coming in right m1, phenom-21 started coming back rapidly.Physician pushed phenom plus till ica bifurcation and phenom-21 more distally.Again they tried to push this pipeline vantage and this time it reached till distal marker of phenom-21.After opening appx.4-5mm of fd, entire system of phenom plus, phenom-21 and this pipeline vantage fell back <(>&<)> came just before mca bifurcation.The physician tried to control the system, but they couldn't do so.Then he re-sheathed this fd and tried to push again distally in inferior mca branch, but couldn't do so.At the end, they decided to take out this fd <(>&<)> put vantage 2.75-20 size with same phenom-21 microcatheter to finish the procedure.Multiple pipeline devices were not being used when movement occurred.There was no friction or difficulty during delivery or positioning? the pipeline was not implanted at the intended location.There were no additional steps (e.G.Additional devices, techniques) required to remove or secure the pipeline.The pipeline did not miss the landing zone.The device did not jump during deployment.The pipeline was placed at least 3 mm past the aneurysm neck on each side.No side branch(es) were covered by pipeline.The tip of the catheter moved during deployment (catheter kickback).There was no friction or difficulty during delivery or positioning.The pipeline did not jump during deployment.Multiple pipelines were not used in the procedure.The tip of the catheter was not under stress.The tip of the catheter moved during deployment.There were no patient symptoms or complications associated with this event.Dapt (dual antiplatelet treatment) was administered (pru level unknown).Angiographic result post procedure: immediate stasis was observed post fd deployment.Ancillary devices: cerebase da long sheath, dac as access products, hybrid-12/14 guidewire.
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
Additional information received reported the per physician the reason of phenom-21 movement could be due to anatomical tortuosity, oversized vantage fd position of phenom plus distal access catheter.
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.
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.

• Brand Name: CATHERA
• 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: 20191625
• Report Number: 2029214-2024-01563
• Device Sequence Number: 8069571
• Product Code: KRA
• UDI-Device Identifier: 00763000399689
• UDI-Public: 00763000399689
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151638
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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: FG13150-0615-2S
• Device Catalogue Number: FG13150-0615-2S
• Device Lot Number: 228323972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/27/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/23/2024; 10/07/2024
• Date Device Manufactured: 02/20/2024
• 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: 61 YR
• Patient Sex: Female