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

Model Number	FG15150-0615-1S
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: pipeline flex with shield technology stent product id ped2-500-25 (lot d068567); 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 during advancement, a pipeline flex with shield technology stent encountered severe resistance in the phenom 27 microcatheter.The stent was damaged and failed to open, and the microcatheter fractured.The patient was undergoing dense mesh flow diversion surgery for treatment of an unruptured, saccular, c6 aneurysm with a max diameter of 5 mm and a 8 mm neck diameter.The landing zone arterial diameter was 4 mm distally and 5 mm proximally.It was noted the patient's vessel tortuosity was severe.Femoral artery access vessel diameter was 8 mm.The angiographic result post procedure reported c7 aneurysm.The vessel segment from c7 to c5 was tortuous, resulting in significant resistance during stent advancement.During stent deployment, elongation and relaxation maneuvers were performed to adjust wall apposition at the outer curve of c6, the stent became flattened and failed to open.On the third attempt, the stent delivery catheter fractured, and the stent was withdrawn from the body together with the p27 microcatheter.The products were replaced with a medtronic products to complete the procedure.No patient symptoms or complications were associated with this event.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).The pipeline was used for an approved indication (on-label).The pushwire was observed to have a break in the distal section.The stent had not been fully deployed and the stent and pushwire were withdrawn from the body together with the microcatheter.

• 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: 24925029
• Report Number: 9617601-2026-02544
• Device Sequence Number: 9142968
• Product Code: QJP
• UDI-Device Identifier: 00763000399702
• UDI-Public: (01)00763000399702(17)280805(10)231973615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

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: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 231973615
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 05/13/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/09/2026
• Date Device Manufactured: 08/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown