MAUDE Adverse Event Report: RENATA MEDICAL RENATA MINIMA STENT SYSTEM

Model Number	FG-0001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 6 mm minima stent was implanted in the right pulmonary artery (rpa) to treat rpa stenosis on (b)(6) 2026.During the index procedure, stent migration and intrapulmonary hemorrhage was reported to renata medical.During a routine echocardiogram performed on (b)(6) 2026, the stent was found to have further migrated and was located adjacent to the right ventricular (rv) wall.The patient was hospitalized and underwent surgical removal of the stent with replacement of the rv-pa conduit on (b)(6) 2026.The device was not returned for evaluation.
Additional Manufacturer Narrative
Based on the available information, during balloon removal in the initial procedure on (b)(6) 2026, the stent was dislodged from the intended location in the rpa and subsequently placed in the lpa.Available information indicates that the reported intrapulmonary hemorrhage was associated with distal pulmonary arterial injury, potentially related to guidewire position during the procedure.The timing and cause of the subsequent migration, resulting in stent location at the rv wall and the need for surgical explant, remain unknown.The device was not returned for evaluation; therefore, device analysis could not be performed.

• 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 CA 92660
• Manufacturer Contact: christina debenedetto ; 4675 macarthur court; suite 1150; newport beach, CA 92660
• MDR Report Key: 25685870
• Report Number: 3027098402-2026-00006
• Device Sequence Number: 4644118
• Product Code: QWC
• UDI-Device Identifier: 00196852801862
• UDI-Public: (01)00196852801862(17)270630(10)Z2460853A
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P240003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 07/01/2026

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-0001
• Device Catalogue Number: FG-0001
• Device Lot Number: Z2460853A
• 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: 06/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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; Hospitalization
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White