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

Model Number 310-31

Device Problems Calcified (1077); Occlusion Within Device (1423)

Patient Problems Calcium Deposits/Calcification (1758); Edema (1820); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: transcatheter, valve-in-valve transapical aortic and mitral valve implantation, in a high risk patient with aortic and mitral prosthetic valve stenoses citation: 2015 apr-jun;18(2):246-51.[doi: 10.4103/0971-9784.154493] authors: harish ramakrishna, patrick a.Devaleria1, john p.Sweeney, farouk mookaram month and year of 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 that an (b)(6) male patient, who had two medtronic porcine bioprosthetic valves implanted 7 years earlier in the aortic (25-mm, serial numbers not provided) and mitral (31-mm, serial numbers not provided) positions, presented with severe aortic and mitral stenosis.A transesophageal echocardiogram (tee) revealed significant prosthetic valve disease.The aortic prosthesis had calcific and obstructed leaflets and elevated mean transvalvular gradient.The mitral prosthesis had calcific, obstructed and severely stenotic leaflets with mild mitral regurgitation.Left ventricular (lv) function was relatively well preserved however there was moderate to severe right ventricular (rv) enlargement and severe rv hypokinesis in conjunction with severe pulmonary hypertension.During the work-up period, the patient developed significant clinical deterioration with worsening fatigue, shortness of breath and edema.In a transcatheter intervention both the aortic and mitral prostheses were successfully replaced with a new non-medtronic prosthetic valves placed inside the diseased bioprosthetic valves.The patient was discharged six days post-operative with markedly improved functional status and acceptable prosthetic valve gradients.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5300036
• MDR Text Key: 33589657
• Report Number: 2025587-2015-01321
• 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,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 310-31
• Device Catalogue Number: 310-31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: 11/16/2015
• Supplement Dates FDA Received: 09/19/2017
• 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: 00081 YR