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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and stent initially performed as anticipated; however, off-label pre-procedural modifications (removing the stent from the balloon) and vessel sizing larger than minima stent labeled sizing have potentially impacted the ability of the stent to be deployed in the intended location and properly fixate.
Event or Problem Description
An 8mm minima stent was used in a procedure to treat a native coarctation in a vessel larger than the stent's labeled implantable range.Prior to the procedure, the physician removed the stent from the balloon to modify the stent.When deployed, the stent missed the target location.Though the stent was stable at the end of the procedure, an x-ray later identified the stent had moved from the deployment location into the brachiocephalic artery.A follow-up procedure was performed two days later to place an additional 8mm minima stent in the stenosis and further fixate the first stent.No device was returned for evaluation.

• 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 92660
• Manufacturer Contact: christina debenedetto ; 4675 macarthur couort; suite 1150; newport beach, CA 92660
• MDR Report Key: 24683215
• Report Number: 3027098402-2026-00003
• Device Sequence Number: 18645530
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)270930(10)Z2460949A
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-0002
• Device Catalogue Number: FG-0002
• Device Lot Number: Z2460949A
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 15 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American