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

Model Number 310F

Device Problem Material Rupture (1546)

Patient Problem Mitral Regurgitation (1964)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years 10 months post implant of this mitral bioprosthetic valve, the patient presented with worsening dyspnea on exertion, severe mitral insufficiency, and a torn leaflet of the mitral bioprosthetic valve.A transesophageal echocardiogram (tee) also indicated severe tricuspid regurgitation, mild to moderate aortic insufficiency, and moderate right ventricular systolic dysfunction.The physician explanted and replaced the mitral bioprosthetic valve.During this procedure, the physician also repaired the patient's native tricuspid valve with an annuloplasty ring and replaced the patient's native aortic valve with a bioprosthetic valve.No other adverse patient effects were reported.Patient medical history: thrombocytopenic.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• 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: 6687905
• MDR Text Key: 79115979
• Report Number: 2025587-2017-01096
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310F
• Device Catalogue Number: 310F29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 80 YR