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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Dysphasia (2195)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
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
It was reported that during a neurovascular flow diversion procedure, a pipeline flex embolization device was used to treat an unruptured saccular aneurysm in the internal carotid artery.The tip of the ped2-500-14 device did not fully expand, and a subsequent attempt with the ped2-500-16 device also resulted in incomplete tip expansion.The physician attempted balloon angioplasty to expand the device, but it was unsuccessful.An enterprise stent was ultimately deployed to assist in fully opening the pipeline, completing the procedure.Post-procedure, the patient experienced aphasia and an inability to move their right hand.Dual antiplatelet treatment was administered, and angiographic results showed the front end of the ped2-500-14 was not fully expanded.The patient's condition is gradually improving.Additional information received reported during the procedure, the physician used a pipeline flex embolization device.However, the tip of the ped2-500-14 did not fully expand.There was a vessel bend slightly below the position where the pipeline was deployed.The first ped2-500-14 was used to attempt resheathing.Later, ped2-500-16 was used to attempt resheathing, wire massage, and balloon techniques.Additional information was received reporting that an echelon catheter was not used during this procedure.The second pipeline (ped2-500-16) device also had an incomplete opening issue at the distal end.The physician subsequently used an enterprise stent to cover and fully deploy the pipeline.Therefore, the ped2-500-16 was implanted in the patient.
Additional Manufacturer Narrative
H6.Fdm/imdrf annex b code updated based on information received which indicated this device was discarded after the procedure.No other new information received.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
Correction: previous report of this event was submitted with an incorrect date in field g3.This report is submitted with the correct date (26-jun-2025).Medtronic received the additional information updated in field g3.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: 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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22302890
• Report Number: 2029214-2025-01440
• Device Sequence Number: 4413646
• Product Code: QJP
• UDI-Device Identifier: 00763000399726
• UDI-Public: (01)00763000399726(17)270206(10)228199695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG15160-0615-1S
• Device Catalogue Number: FG15160-0615-1S
• Device Lot Number: 228199695
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided; 06/26/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/23/2025; 07/23/2025
• Date Device Manufactured: 02/06/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female