MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA STENT SYSTEM

Model Number	FG-0001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, the device and stent performed as intended during the initial implant procedure on (b)(6) 2025, with no reported complications.During a follow-up catheterization on (b)(6) 2026, it was noted that the stent migrated and an aneurysm had developed.The timing and cause of the stent migration and aneurysm development remain unknown.No product was returned for evaluation; therefore, device analysis could not be performed.
Event or Problem Description
A 6 mm minima stent was used to treat a native coarctation on (b)(6) 2025.No intra-procedural complications or adverse events were reported to renata medical at the time of this procedure.On (b)(6) 2026, a follow-up catheterization procedure was performed due to an increased gradient identified during clinical evaluation.During this procedure, stent migration and a posterior medial aneurysm were observed.The device was not returned for evaluation.No additional device performance data information is available at this time.

• Brand Name: RENATA MINIMA STENT SYSTEM
• Common Device Name: MINIMA STENT SYSTEM
• 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: christina debenedetto ; 4675 macarthur court; suite 1150; newport beach, CA 92660
• MDR Report Key: 25368257
• Report Number: 3027098402-2026-00005
• Device Sequence Number: 9847666
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)250711(10)Z2460459C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P240003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Expiration Date: 07/11/2025
• Device Model Number: FG-0001
• Device Catalogue Number: FG-0001
• Device Lot Number: Z2460459C
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: Other
• Patient Age: 11 MO
• Patient Sex: Male