MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Degraded (1153)

Patient Problems Aneurysm (1708); Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Chest Pain (1776); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Citation: vukadinovikj a et al.Transcatheter valve-in-valve implantation versus surgical redo aortic root replacement in patients with degenerated freestyle aortic bioprosthesis.Catheter cardiovasc interv.2021 feb 1.Doi: 10.1002/ccd.29507.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding the feasibility and outcomes of transcatheter aortic valve-in-valve implantation (viv tavi) versus redo surgical aortic valve replacement (redo savr) in patients with degenerated freestyle valves.All data was collected from a single center between january 2002 and february 2020.The study population included 35 patients andwas predominantly male with a mean age of 69 years.All patients were previously implanted with medtronic freestyle aortic bioprosthetic valves.No unique device identifier numbers were provided.Of the 35 freestyle patients, three deaths occurred within thirty days after viv tavi.No deaths occurred within thirty days after redo savr.None of the deaths were directly associated with medtronic product as non-medtronic transcatheter valve systems were used to replace the freestyle valves.Of the 35 freestyle patients, 25 patients underwent viv tavi and 10 patients underwent redo savr.The time from freestyle implant to viv tavi and redo savr was 11.3 and 6.0 years, respectively.Reasons for reintervention included: moderate to severe regurgitation, stenosis, or sinus ofvalsalva aneurysm.Of the 10 redo savr patients, 7 patients were retreated with freestyle valves and 3 patients were treated with non-medtronic mechanical conduits.The following adverse events were observed after redo savr: new permanent pacemaker implantation, new bundle branch and/or atrioventricular block, new onset atrial fibrillation, life-threatening or major bleeding, reintubation, reintervention, and hospital readmission for dyspnea and worsening of heart failure.In addition, the authors noted that of all 2,464 patients who underwent aortic root surgery with the freestyle at their institution between january 2002 and february 2020, the following adverse events had occurred after the initial implant procedure: permanent pacemaker or implantable cardioverter defibrillator implantation, unspecified atrioventricular block, unspecified bundle branch block, atrial fibrillation, cardiac arrhythmias, hospital readmission, severely depressed left ventricular function, valve degeneration/failure, subacute/acute endocarditis, worsening heart failure, chest pain, extracardiac arteriopathy, and arterial hypertension.No additional adverse patient effects or product performance issues were reported.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11456135
• MDR Text Key: 239401206
• Report Number: 2025587-2021-00812
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR