MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION 3F AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 1000

Device Problem Gradient Increase (1270)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

Citation: stefanelli g, et al.Intermediate-term outcomes after aortic valve replacement with the medtronic 3f stentless prosthesis.Ann thorac surg.2021 jun;111(6):1975-1982.Doi: 10.1016/j.Athoracsur.2020.07.053.Epub 2020 oct 10.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 early and intermediate-term patient outcomes after aortic valve replacement with the 3f stentless valve.All data was retrospectively collected from a single center between march 2007 and august 2015.The authors noted the post-operative follow-up ranged from 6 months to 11.5 years.All 226 patients included in the study population (predominantly male, mean age 74.2 years) underwent aortic valve replacement with the medtronic 3f aortic bioprosthesis.No unique device identifier numbers were provided.One in-hospital death occurred due to sepsis.No further details were disclosed, but it¿s reasonably possible that the 3f valve may have been a factor in this death.The other 3 in-hospital deaths were caused by multi-organ failure (2) and enteric ischemia (1).During follow-up, an additional 59 deaths occurred (non-cardiac causes = 44, cardiac causes = 15).No statement was made suggesting a causal or contributory relationship between the 3f valve and these deaths.Among all patients, non-death adverse events included: re-exploration for bleeding; permanent pacemaker implantation; peri-operative myocardial infarction; mild central aortic insufficiency; elevated gradients; cerebrovascular events; unspecified structural deterioration; and need for valve-related reoperation/explantation (endocarditis = 3 cases, unspecified structural valve deterioration = 4 cases).No additional adverse patient effects or product performance issues were reported.

• Brand Name: 3F AORTIC BIOPROSTHETIC HEART VALVE
• 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: 12407682
• MDR Text Key: 269437696
• Report Number: 2025587-2021-02719
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060025
• 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: 09/01/2021

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: 1000
• Device Catalogue Number: 1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/01/2021
• 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: 74 YR