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); Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Citation: bozso et al.Long-term outcomes following mechanical or bioprosthetic aortic valve replacement in young women.Cjc open.2020 jun 30;2(6):514-521.Doi: 10.1016/j.Cjco.2020.06.015.Ecollection 2020 nov.Earliest date of publish used for date of event.Medtronic products referenced: freestyle (pma# p970031, product code lwr), mosaic (pma# p990064, product code dye).Earliest approved product used for product code and pma#.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 long-term outcomes following mechanical or bioprosthetic aortic valve replacement in women less than 50 years old.All data were collected from the alberta provincial project for outcome assessment in coronary heart disease (approach) database between january 1, 2004, and september 16, 2018.The study population included 162 patients (female, mean age 39 years).Of those, 24 patients were implanted with a medtronic freestyle (n=23) or mosaic (n=1) bioprosthetic valve.No unique device identifier numbers were provided.Of the 162 patients, 114 were then propensity-matched for further analysis.Among all patients who received a bioprosthetic valve, 5 deaths occurred which included no deaths within 30 days, one death within one year, and four deaths beyond one year.No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients who received a bioprosthetic valve, adverse events included: new-onset atrial fibrillation, new permanent pacemaker, sepsis, cardiac arrest, stroke, congestive heart failure, intracranial bleeding requiring hospitalization, and structural valve degeneration requiring repeat aortic valve replacement.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12362459
• MDR Text Key: 267966656
• Report Number: 2025587-2021-02646
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/24/2021

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: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39 YR