MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 04/25/2020

Event Type  Injury  

Manufacturer Narrative

Citation: tamirat et al.Contemporary outcomes of aortic and mitral valve surgery for rheumatic heart disease in (b)(6).J thorac cardiovasc surg.(b)(6) 2021;162(6):1714-1725.E2.Doi: 10.1016/j.Jtcvs.2020.02.139.Epub (b)(6) 2020.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 via literature regarding outcomes of aortic and mitral valve surgery for rheumatic heart disease in (b)(6).All data were collected from a (b)(6) center between 2009 and 2017.The study population included 240 patients (predominantly female, mean age 19 years).Multiple manufacturer¿s devices were implanted in the study population.Among all patients eight were implanted with a medtronic porcine bioprosthetic valve (n=2) or mechanical valve (n=6) in either the aortic or mitral valve position.No model names or other unique device identifier numbers were provided.Among all bioprosthetic and mechanical valve patients, adverse events included: stroke, major bleeding requiring intervention, endocarditis, svd, new onset atrial fibrillation (afib), and wound infection.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL TISSUE 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14115946
• MDR Text Key: 290694863
• Report Number: 2025587-2022-00988
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: ET
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female