MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG15160-0615-1S
Medical Device Problem Codes	Retraction Problem (1536); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
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 of two pipeline devices that appeared twisting and one that had failure to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm located in the right ophthalmic carotid with a max diameter of 7.4mm and a 5.6mm neck diameter.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with a "6f" vessel diameter.The angiographic result post procedure was the, "aneurysm successfully embolized." there are images are available for review.No medical or surgical intervention was needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.There was no injury as a result of the event.The landing zone (artery size) was 3.7mm distal and 4.9mm proximal.It was reported that during the treatment of the aneurysm with a 5x18 pipeline flow diverter, it did not open, showing twisting in the distal region of the device.The entire system was retracted and the device is now inside the phenom microcatheter.A new passage of the phenom with an avigo micro guide was initiated, advanced with a 5x20 stent, repositioned again in the distal portion of the aneurysm, and the device presented a twist in the distal region.The doctor performed some maneuvers to reposition and sheath the device, but without success.The entire system was removed with the phenom.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The pipeline was not used for any indication that is not approved (off-label).The catheters were flushed as indicated in the ifu.

• Brand Name: PHENOM CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24791807
• Report Number: 9617601-2026-02285
• Device Sequence Number: 15654868
• Product Code: QJP
• UDI-Device Identifier: 00763000399726
• UDI-Public: (01)00763000399726(17)280802(10)231955680
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K180959
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2026

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: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Device Lot Number: 231955680
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 06/02/2026; 06/23/2026; 06/23/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/12/2026; 06/23/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• 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: 50 YR
• Patient Sex: Female