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

Model Number 305_MOSAIC

Device Problem Gradient Increase (1270)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

Citation: lluri, g.Md et al.Incidence and outcome of infective endocarditis following percutaneous versus surgical pulmonary valve replacement.Catheter cardiovasc interv.(2017) 1-8 doi 10.1002/ccd.27312 earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding the incidence of endocarditis after the implant of a percutaneous pulmonary valve (134) versus a surgical pulmonary valve (208).All data were collected from a single center between 2010 and 2016.The study population included 242 patients, which were implanted with either a medtronic transcatheter pulmonary valve or surgical valve or a non-medtronic transcatheter pulmonary valve or surgical valve.Serial numbers were not provided.The surgical valve study population was predominantly male; mean age 23.3 ± 16.1 years.It was reported that two patients had a previously implanted 23mm hancock or 19mm mosaic.Adverse events among these patients included mild to severe pulmonary regurgitation and increased gradient measurements.The surgical valves were replaced valve-in-valve with a transcatheter pulmonary valve.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC AORTIC 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: 7119243
• MDR Text Key: 94923775
• Report Number: 2025587-2017-02442
• 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: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305_MOSAIC
• Device Catalogue Number: 305_MOSAIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• 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: 23 YR