MAUDE Adverse Event Report: Renata Medical 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	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, an 8mm minima stent system was implanted by dr.(b)(6) to treat coarctation of the aorta.The patient then underwent the glenn procedure with sano takedown on (b)(6) 2026; this was unrelated to the minima stent implant procedure.On (b)(6) 2026, after the (b)(6) 2026 surgery, dr.(b)(6) performed an echocardiogram and found that the stent had moved approximately 10mm proximal to the lesion.On (b)(6) 2026 another 8mm minima stent system was placed during a subsequent transcatheter procedure to relieve the stenosis.
Additional Manufacturer Narrative
The implanting physician (dr.(b)(6)) reported to renata medical that the stent movement was approximately 10mm proximally, above the coarctation.The implanting physician noted that this movement appeared to result from the operating room surgery, as it was neither consistent with the flow of blood nor typical of migration.

• Brand Name: 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 CA 92660
• Manufacturer Contact: christina debenedetto ; 4675 macarthur court; suite 1150; newport beach, CA 92660 ; +1(203)767-4231
• MDR Report Key: 50791061
• Report Number: 3027098402-2026-00007
• Device Sequence Number: 9570040
• Product Code: PNF
• UDI-Device Identifier: 00196852805037
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Model Number: FG-0002
• Device Catalogue Number: FG-0002
• Device Lot Number: Z2460903A
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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 MO
• Patient Sex: Male
• Patient Weight: 12 LB
• Patient Race: White