MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA 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	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and stent initially performed as anticipated.However, the underlying tissue condition, existing avp plug and size of the vessel affected the outcome.The presence and size of the avp applied pressure to the stent.
Event or Problem Description
One 6 mm minima stent was used to treat a left pulmonary artery (lpa) stenosis with difficult underlying vessel conditions.After the stent was placed, final angiograms confirmed the stent was properly located so the minima system and guidewire were removed.Following the minima implant, the physician proceeded with an unrelated procedure, after which fluoroscopy revealed that stent shifted towards the main pulmonary artery (mpa).The physician intervened and successfully repositioned the stent into the right pulmonary artery (rpa) using a guidewire.The stent stabilized in the rpa without a balloon and the stenosis was left untreated.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 ste 1150; newport beach CA 92660
• Manufacturer (Section G): RENATA MEDICAL; 4675 macarthur court ste 1150; newport beach CA 92660
• Manufacturer Contact: alex zoellick ; 4675 macarthur court suite 1150; newport beach, CA 92660 ; 8478671926
• MDR Report Key: 21574574
• Report Number: 3027098402-2025-00002
• Device Sequence Number: 8940445
• 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): 03/11/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2025
• Device Model 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: 02/11/2025
• Initial Report FDA Received Date: 03/11/2025
• 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: 6 MO
• Patient Sex: Female
• Patient Weight: 9 KG
• Patient Race: White