MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number 30519

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

Citation: sá mp, et al.Bioprosthetic valve fracture for valve-in-valve transcatheter aortic valve implantation in patients with structural valve degeneration: systematic review with meta-analysis.J card surg.2021 dec;36(12):4722-4731.Doi: 10.1111/jocs.16032.Epub 2021 sep 27.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 outcomes of bioprosthetic valve fracture (bvf) in valve-in-valve transcatheter aortic valve implantation (viv-tavi) for patients with structural valve degeneration of bioprosthetic surgical valves.All data was collected from a meta-analysis review of four studies published between 2017 and 2021.Of the 242 patients included in the study population (predominant gender not reported for all studies, overall mean age of 78.5 years), approximately 57 were previously implanted with a medtronic mosaic bioprosthetic aortic valve, while approximately 135 underwent viv-tavi with a medtronic transcatheter valve (corevalve = ~77, evolut r/evolut pro = ~58).No unique device identifier numbers were provided.After pooling the data from all four studies included in the analysis, the authors reported an overall 30-day mortality rate of 2.1%.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.The authors noted that a proportion of the study population had pre-existing prosthesis-patient mismatch before viv-tavi due to the implant of a small valve size during surgical aortic valve replacement.All mosaic patients underwent viv-tavi with bvf because of structural valve degeneration.Types of degeneration included: stenosis, regurgitation, and mixed stenosis/regurgitation.Additionally, the authors observed the following adverse effects before viv-tavi: heart failure and low ejection fraction (<(><<)>50%).After viv-tavi with bvf, medtronic transcatheter valves may have been associated with the following adverse events: annular rupture, stroke, paravalvular leak, permanent pacemaker implantation, coronary obstruction, coronary obstruction requiring emergent surgical removal of the transcatheter valve, and prosthesis-patient mismatch.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• 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: 13054365
• MDR Text Key: 283244556
• Report Number: 2025587-2021-03808
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30519
• Device Catalogue Number: 30519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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; Required Intervention
• Patient Age: 79 YR