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

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Arrhythmia (1721); Endocarditis (1834); Transient Ischemic Attack (2109); Low Cardiac Output (2501); Blood Loss (2597); Thromboembolism (2654)

Event Date 06/28/2003

Event Type  Injury  

Manufacturer Narrative

Citation: melina g et al.Mid-term pattern of survival, hemodynamic performance and rate of complications after medtronic freestyle versus homograft full aortic root replacement: results from a prospective randomized trial.J heart valve dis.2004 nov;13(6):972-5; discussion 975-6.Presented at the second biennial meeting of the society for heart valve disease, 28th june-1st july 2003, palais des congrès, paris, france.Doi: not available ¿ literature pdf attached.Earliest date of publish used for event date in b3.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.Additional patient code(s): c50470, c50641, c50781, c50861.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the mid-term outcomes in patients who underwent aortic valve replacement with a freestyle bioprosthesis or a homograft.All data were collected from a single center.The study population included 147 patients and was predominantly male with a mean age of 66 years.Of those, 80 were implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all freestyle patients, the early mortality and late survival rates were 9.1% and 83%, respectively.No other details were reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all freestyle patients, adverse events included: bleeding that required reoperation, mild aortic regurgitation, transient ischemic attack, thromboembolism, endocarditis, low cardiac output that required medication or intra-aortic balloon pump use, and post-operative atrial or ventricular arrhythmias.Based on the available information, medtronic product was associated with the adverse events.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9512691
• MDR Text Key: 185072992
• Report Number: 2025587-2019-03874
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

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: 12/03/2019
• Initial Date FDA Received: 12/23/2019
• 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): Required Intervention
• Patient Age: 66 YR