MAUDE Adverse Event Report: RENATA MEDICAL MINIMA STENT SYSTEM

Model Number	FG-0001
Medical Device Problem Codes	Device Slipped (1584); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because of the size of the patient, carotid access was used to reach the lesion location.Arduous vasculature, medication and access location contributed to difficulties encountered during the procedure.
Event or Problem Description
Initial placement of the first minima stent was deployed distal from the intended deployment location preventing the coarctation from being treated.An attempt to telescope a second stent within the first stent was intended to simultaneously treat the coarctation and secure the first stent in place; however, the second stent was also placed distal to the intended location, resulting in neither stent treating the coarctation.A third stent was used to successfully treat the coarctation without incident.After completion of the procedure, the telescoped stents were observed to migrate distally as a result of not being secured within a stenotic lesion.The day after the procedure, x-rays confirmed the telescoped stents fixated in a smaller diameter vessel.Following the implant procedure, an unrelated transcatheter procedure was performed.During which, the telescoped stents were re-dilated as a precautionary measure.Device was not returned for evaluation.

• Brand Name: MINIMA STENT SYSTEM
• Common Device Name: MINIMA 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: benjamin krebs ; 4675 macarthur ct, suite 1150; newport beach, CA 92660 ; 9254707254
• MDR Report Key: 20908816
• Report Number: 3027098402-2024-00001
• Device Sequence Number: 15400657
• Product Code: PNF
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)250711(10)Z2460459C
• 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: 2024
• 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): 11/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2025
• 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: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• 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: Other
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG