MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA STENT SYSTEM; MINIM STENT SYSTEM

Model Number	FG-0001
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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 6mm minima stent was used to treat an aortic re-coarctation.After the stent was placed, the physician attempted to improve fixation by post-dilating the stent with the same balloon.When the balloon was deflated, imaging identified that the stent migrated distally through the descending aorta such that it no longer treated the stenosis.A second system was tracked to the lesion and as the balloon was exposed, the outer shaft pulled the first implant further distally in the descending aorta.The second stent resulted in successful stenosis relief and maintained fixation within the vessel.The first implant was post-dilated with an off-the-shelf balloon to prevent further migration.No device was returned for evaluation.

• Brand Name: RENATA MINIMA STENT SYSTEM
• Common Device Name: MINIM STENT SYSTEM
• Manufacturer (Section D): RENATA MEDICAL; 4675 macarthur ct suite 1150; newport beach CA 92660
• Manufacturer (Section G): RENATA MEDICAL; 4675 macarthur ct. suite 1150; newport beach CA 92660
• Manufacturer Contact: alex zoellick ; 4675 macarthur ct. suite 1150; newport beach, CA 92660 ; 8478671926
• MDR Report Key: 22810068
• Report Number: 3027098402-2025-00005
• Device Sequence Number: 7797960
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)260531(10)Z2460459C
• 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: 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): 08/11/2025

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
• 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: 06/30/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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: Required Intervention
• Patient Age: 19 DA
• Patient Sex: Male
• Patient Weight: 4 KG