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

Model Number 310_MOSAIC

Device Problems Occlusion Within Device (1423); Perivalvular Leak (1457)

Patient Problems Mitral Regurgitation (1964); Stenosis (2263)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

Citation: kliger c percutaneous complete repair of failed mitral valve prosthesis: simultaneous closure of mitral paravalvular leaks and transcatheter mitral valve implantation - single-center experience.Eurointervention.2015 mar;10(11):1336-45.Doi: 10.4244/eijy14m05_01.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a single-center experience on complete transcatheter repair of a degenerated mitral bioprosthesis.All data were collected from a single center between march 2012 to october 2012.The study population included 5 patients (predominantly male; mean age 73 years), 1 patient had been previously implanted with medtronic mosaic valve and all were implanted valve-in-valve with medtronic melody valves.The serial numbers were not provided.Medtronic received information that (b)(6) year-old male patient had been implanted with a 29 mm medtronic mosaic valve and two occluders were implanted for paravalvular leak (pvl).Six-months post implant, a 24 mm medtronic melody valve was implanted valve-in-valve (viv) due to severe stenosis and regurgitation.Mild paravalvular leak (pvl) was noted post-implant.No additional adverse patient effects were reported.Medtronic received information that (b)(6)-year-old male patient had been implanted with a non-medtronic valve into mitral position and two occluders were implanted for paravalvular leak (pvl).Eleven years post implant, a 24 mm medtronic melody valve was implanted valve-in-valve due to severe regurgitation and mitral stenosis.Embolization of the melody valve was noted post-implant.An attempt was made to secure the valve in place using a second melody valve (melody viv) without success.The valves were surgically replaced with a non-medtronic valve without complication.No additional adverse patient effects were reported.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC MITRAL 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7333745
• MDR Text Key: 102205810
• Report Number: 2025587-2018-00550
• Device Sequence Number: 1
• Product Code: LWR
• 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: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310_MOSAIC
• Device Catalogue Number: 310_MOSAIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• 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: 73 YR