MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA STENT SYSTEM

Model Number	FG-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Convulsion/Seizure (4406); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/11/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The delivery system and stent performed as anticipated with no reported malfunctions.Review of the case by the medical monitor and investigator found that the minima stent was likely not related to the adverse event.
Event or Problem Description
The minima stent was reported in a severe adverse event during patient participation in the minima post-approval study (b)(6).A 6mm minima stent was used to treat an aortic coarctation on (b)(6) 2026.The stent placement relieved the pressure gradient, and angiogram confirmed a successful result.On (b)(6) 2026, the patient became bradycardic and was placed on ecmo following 45 minutes of cpr without return of spontaneous circulation.On (b)(6) 2026, imaging revealed ischemic stroke, the patient was discontinued from ecmo support and pronounced deceased.No device was returned for evaluation.

• Brand Name: RENATA MINIMA STENT SYSTEM
• Common Device Name: MINIMA STENT
• Manufacturer (Section D): RENATA MEDICAL; 4675 macarthur court; suite 1150; newport beach CA 92660
• Manufacturer (Section G): RENATA MEDICAL; 4675 macarthur court; suite 1150; newport beach CA 92660
• Manufacturer Contact: alex zoellick ; 4675 macarthur court; suite 1150; newport beach 92660 ; 8478671926
• MDR Report Key: 24837886
• Report Number: 3027098402-2026-00004
• Device Sequence Number: 13058094
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)270630(10)Z2460853A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P240003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: FG-0001
• Device Catalogue Number: FG-0001
• Device Lot Number: Z2460853A
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White