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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device and stent initially performed as anticipated; however, the stent did not fixate as intended due to anatomical complexities.Surgical intervention was performed due to distal transverse arch hypoplasia.During the reconstruction of the aortic arch, the minima stent was partially cut.
Event or Problem Description
On (b)(6) 2025, two 6mm minima stents were used to treat native coarctation.The initial stent moved from the initial placement location due to difficult location and sizing of the lesion.After the second stent was placed, there were no adverse events recorded and the lesion was treated.During follow up, it was determined that surgical intervention would be pursued due to persisting hypoplastic transverse arch.It was acknowledged that the stent could be redilated, but the hypoplastic transverse arch would require surgery, so both were addressed during surgery.On (b)(6) 2026, the stent was partially cut through longitudinally during a procedure to reconstruct the aortic arch as well as treat the measured gradient.

• 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 couort; suite 1150; newport beach, CA 92660
• MDR Report Key: 24565249
• Report Number: 3027098402-2026-00002
• Device Sequence Number: 13163300
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)260531(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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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: Other
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White