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

Model Number MDT-TISSUE VALVE

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

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Left Ventricular Dysfunction (1947)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

Citation: zenses as et al.Haemodynamic outcomes following aortic valve-in-valve procedure.Open heart.2018 jul 9;5(2):e000854.Doi: 10.1136/openhrt-2018-000854.Earliest date of publish used for date of event in b3.Medtronic products referenced: mosaic (pma# p990064, pro code dye), freestyle (pma# p970031, pro code lwr), hancock (pma# p870078, pro 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 from a literature article regarding a comparison of aortic valve hemodynamics following surgical aortic valve replacement (savr) and transcatheter aortic valve-in-valve (viv) implantation.All data were retrospectively collected from a single center between 2009 and 2017.The study population included 79 patients (predominantly male, mean age 75 years) who underwent transcatheter aortic viv implantation for bioprosthetic valve degeneration (stenosis, regurgitation, or mixed).The mean duration from savr to viv implantation was 11 years.During savr, 24 patients were implanted with medtronic surgical aortic valves: mosaic (15), freestyle (8), and hancock (1).During viv implantation, 28 patients were implanted with medtronic transcatheter aortic valves: corevalve or evolut r.No serial numbers were provided.Among all medtronic surgical aortic valve patients, transcatheter aortic viv implantation was performed for aortic stenosis, moderate to severe aortic regurgitation, or mixed valve dysfunction (combination of stenosis and regurgitation).Additional adverse patient effects included: elevated mean transvalvular pressure gradients, reduced left ventricular ejection fraction, prosthesis-patient mismatch, and mild aortic regurgitation.Based on the available information, medtronic product was associated with the adverse events.Adverse events that occurred during and after transcatheter aortic viv implantation included: need for a second transcatheter valve, coronary occlusion, valve malposition or embolization, permanent pacemaker implantation, new onset atrial fibrillation, major vascular complications, major bleeding, prosthesis-patient mismatch, mild to moderate aortic regurgitation, and high residual mean pressure gradients.Based on the available information, medtronic transcatheter aortic valves may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: 10804474
• MDR Text Key: 215325554
• Report Number: 2025587-2020-03467
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P870078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: 11/02/2020
• 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: 75 YR