MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	107F-079-105
Medical Device Problem Codes	Unintended Movement (3026); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that after guiding the phenom 27 to the distal end of the aneurysm, the pipeline was inserted and tried to expand it from the distal end; the rist was stuck in the proximal end, so the product was collected.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were reported.Additional information was received stating that the aneurysm was located in the c5 clinoid classification with a max diameter of 5mm and neck diameter of 3mm.There seemed to be some resistance in the insertion/during delivery.No defects in particular occurred with the pipeline and phenom 27.The rist was noted to have been dropped to the proximal end.The physician said that this was caused by a problem with the blood vessels.In order to complete the procedure, the physician tried again with a fubuki xf and was able to place it successfully.Ancillary devices include a 107f079105 guiding catheter, phenom27 microcatheter, synchro select standard 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 there was resistance during pipeline deployment, and there was a deployment failure at the distal position.No complaint against phenom27.No other abnormalities or malfunctions occurred.Vessel tortuosity was severe.Fa was implemented and the procedure was completed.The cause of the failure to open was speculated that it was due to the shape of the blood vessels and the shape of the aorta.The pipeline was placed in a vessel bend when it failed to open.No additional steps were taken to open the pipeline.Continuous catheter flush was administered during the procedure.No damage was observed to the pipeline pushwire or 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.
Event or Problem Description
Additional information was received stating that due to the strong vascular tortuosity present during the guidance of the rist, the pipeline was guided under these conditions.As a result, the delivery wire was more rigid, and its recoil caused both the rist and the wire to slip down to the aorta, necessitating retrieval.
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: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: 22211712
• Report Number: 2029214-2025-01379
• Device Sequence Number: 8158724
• Product Code: QJP
• UDI-Device Identifier: 00763000413781
• UDI-Public: (01)00763000413781(17)270813(10)25102-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191551
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2025

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: 107F-079-105
• Device Catalogue Number: 107F-079-105
• Device Lot Number: 25102-01
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/22/2025; 09/22/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/20/2025; 10/20/2025
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown