MAUDE Adverse Event Report: RENATA MEDICAL INC. MINIMA STENT SYSTEM; PULMONARY STENT

Lot Number P008470

Patient Problems Vomiting (2144); Obstruction/Occlusion (2422); Increased Respiratory Rate (2486); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/30/2023

Event Type  Injury  

Event Description

A 7-month-old white male subject (b)(6) experienced worsening heart failure-with ejection fraction (ef) 20% and increased mean gradient across the stent while enrolled in ptc-0009, "a multicenter pivotal study of neonatal, infant, and young child vascular stenoses studying the renata minima stent." the study device was implanted on (b)(6) 2023.The subject's medical history was relevant for hypoplastic left ventricle, critical coarctation of the aorta, ventricular septal defect, patent ductus arteriosus, patent foramen ovale since (b)(6) 2023 and severe pulmonary hypertension and moderate to severe right ventricle (rv) dilation since (b)(6) 2023 the subject's concomitant medications taken within two weeks of the event onset included clopidogrel as antithrombotic prophylaxis since (b)(6) 2023 to ongoing, acetylsalicylic acid as antithrombotic prophylaxis since (b)(6) 2023 to ongoing, furosemide for diuretic-pulmonary over circulation since (b)(6) 2023 to ongoing, dextrose with sodium chloride (nacl) for maintenance intravenous fluids since (b)(6) 2023 to ongoing and lansoprazole for reflux prophylaxis since (b)(6) 2023 to ongoing.On (b)(6) 2023, 173 days after study device was implanted the subject developed worsening heart failure with ef of 20%.The subject was hospitalized on this same day after he presented to a scheduled high-risk cardiology appointment with tachypnea, global retractions and a 1¿2-week history of vomiting with feedings.The subject underwent labs and chest x-ray (cxr) and results were pending at the time of this report while the echocardiogram showed worsening heart failure with ef of 20%.He was transferred to the emergency room (er) where he was placed on a high flow nasal cannula (hfnc) at 2 l with 21% fraction of inspired oxygen (fio2) and was ordered to be nothing by mouth (npo).Intravenous (iv) fluids were started, and he was admitted to the cardiovascular intensive care unit (cvicu) for further management.On (b)(6) 2023, 174 days after study device was implanted the subject further developed an increased mean gradient across the stent.A follow-up echocardiogram revealed improved left ventricle ejection fraction (lvef) of 45-50%, but there was an increased gradient across the aortic arch stent with a mean gradient of 28 millimeters of mercury (mmhg).A multidisciplinary decision was made to take the subject to the operating room (or) for repair of coarctation, ventricular septal defect (vsd) and removal of flow reducers.The stent had been observed to be causing left bronchial compression, the decision was made to not dilate the stent with balloon in the catheterization lab.On (b)(6) 2023, the subject was taken to the or for a procedure that included patch closure of two large vsds, primary closure of one small vsd and the removal of pulmonary flow reducers.The minima stent was removed, and the aorta was reconstructed using a femoral vein homograft.The subject returned from the operating room on dopamine, calcium chloride, dexmedetomidine hydrochloride, epinephrine, and morphine continuous infusions.He was weaned off the morphine, dexmedetomidine hydrochloride, dopamine, and epinephrine.He had continued the calcium chloride and milrinone infusions.The subject has remained hospitalized in the cvicu as of the date of this report i.E., 06-dec-2023 action taken with respect to the event of worsening heart failure with ef of 20% was reported as medication given while for the event of increased mean gradient across the stent was reported as surgery.The outcome of the event worsening heart failure with ef of 20% was reported as resolving while for the event of increased mean gradient across the stent was reported as resolved on 01-dec-2023.The subject was not yet discharged from the hospital at the time.On 04-dec-2023, the investigator reported the severe event of worsening heart failure ef-20% was unrelated to the study device and procedure while the severe event of increased mean gradient across the stent was considered as probably related to the study device and procedure.The event worsening heart failure ef-20% was considered as life-threatening illness or injury and required inpatient hospitalization while the event of increased mean gradient across the stent necessitated medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment of a body structure or body function and resulted in prolongation of existing hospitalization.Both events were reported as unanticipated.On 10-dec-2023, mm case causality assessment: the medical monitor assessed the event of increased mean gradient across the stent as probably related while the event of worsening heart failure-ef 20% as unrelated to the study procedure and device.Both events were considered as unanticipated.When initially being notified of the stent removal, renata medical was unclear to what extent the study device contributed to the decision to proceed with open surgical intervention.After learning more about the complex nature of the patient's medical history and the number of other treatments being performed at the time of intervention, it appears the decision to remove the stent is a piece of a larger decision for the patient and the treatment team.Bronchial compression and other geometric constraints due to surrounding anatomical structures is commonly discussed in current intervention planning.If additional risks are identified after further review of the case, renata medical will re-evaluate current risk-benefit analysis.

• Brand Name: MINIMA STENT SYSTEM
• Type of Device: PULMONARY STENT
• Manufacturer (Section D): RENATA MEDICAL INC.; 4695 macarthur court, suite 440; newport beach CA 92660
• MDR Report Key: 18365436
• MDR Text Key: 331179563
• Report Number: MW5149402
• Device Sequence Number: 1
• Product Code: QWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Lot Number: P008470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETYLSALICYLIC ACID.; CLOPIDOGREL.; DEXTROSE WITH SODIUM CHLORIDE (NACL).; FUROSEMIDE.; LANSOPRAZOLE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic
• Patient Race: White