MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-115-08MP
Medical Device Problem Codes	Unintended Movement (3026); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a pipeline encountered resistance in the distal end of the marksman.After the access was established (guiding+6f navien+marksman), the pipeline could not be delivered to the right place.The highest it reached was near the posterior communicating artery.The stent was deployed in situ.During the process, the system slipped as a whole and could not reach the lesion.It was withdrawn as a whole, and the stent and catheter were replaced to complete the operation.The stent had become stuck during delivery.The physician had released the load (slack) in the system in an attempt to resolve the issue, but the issue did not resolve.There was no damage to the catheter and pushwire.The pipeline was used for an indication that is approved (on-label).The reported device and any accessory devices were prepared and the catheter was flushed continuously with heparanized saline as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of a saccular, unruptured left ophthalmic artery aneurysm with a max diameter of 3mm and a 2mm neck diameter.Landing zone: distal: 3.6mm and proximal: 4.1mm.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with an 8mm diameter.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed a cavernous sinus fistula.
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 navien intermediate catheter was no involved in the reported event of the "the system s lipped as a whole"; there was no issue with the navien.It was indicated that the pipeline was delivered around the posterior communicating artery at the further possible point and slipped/jumped during deployment.The cause was not determined but considered possibly due to resistance or to the patient's vessel tortuosity and model/size of the pipeline stent.One pipeline was being used at the time of the event.The tip of the marksman catheter was moved during pipeline deployment.Based on additional information received on 18jun2025, the navien catheter device is no longer considered a complaint or reportable.Mdr decision corrected too not reportable.No additional supplemental mdr's are required unless additional information received indicates a reportable event.
Additional Manufacturer Narrative
B5 updated with additional information received.Based on additional information received on 18jun2025, the navien catheter device is no longer considered a complaint or reportable.Mdr decision corrected too not reportable.No additional supplemental mdr's are required unless additional information received indicates a reportable event.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: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 22117554
• Report Number: 2029214-2025-01274
• Device Sequence Number: 7063341
• Product Code: DQY
• UDI-Device Identifier: 00847536017924
• UDI-Public: (01)00847536017924(17)260613(10)B745521
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• 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,Followup
• Report Date (Section B): 06/30/2025

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 Expiration Date: 06/13/2026
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B745521
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 06/13/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 73 KG