MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA STENT SYSTEM

Model Number	FG-0002
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and stent initially performed as anticipated; however, underlying tissue compliance and vessel geometry impacted the ability for the stent to fixate.
Event or Problem Description
One 8 mm minima stent was used to treat a native aortic coarctation.After the stent was placed, final angiography indicated that the stent was placed in the target location.Routine post-procedural imaging identified that the stent migrated distally through the descending aorta below the diaphragm.Four days after the implant procedure, the patient underwent surgery to repair the coarctation.During the repair, the stent was removed.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 115; newport beach CA 92660
• Manufacturer (Section G): RENATA MEDICAL; 4675 macarthur court suite 115; newport beach CA 92660
• Manufacturer Contact: alex zoellick ; 4675 macarthur court suite 1150; newport beach 92660 ; 8478671926
• MDR Report Key: 21973209
• Report Number: 3027098402-2025-00003
• Device Sequence Number: 15752477
• Product Code: PNF
• UDI-Device Identifier: 00196852805037
• UDI-Public: (01)00196852805037(17)261231(10)Z2460661C
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P240003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 05/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-0002
• Device Catalogue Number: FG-0002
• Device Lot Number: Z2460661C
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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
• Patient Age: 16 MO
• Patient Sex: Female
• Patient Weight: 11 KG