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

Model Number 305

Device Problem Gradient Increase (1270)

Patient Problems Corneal Pannus (1447); Syncope (1610); Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 04/27/2015

Event Type  Injury  

Event Description

Medtronic received information that approximately three months post implant of this bioprosthetic aortic valve, the patient presented with shortness of breath and syncope, necessitating a permanent pacemaker be implanted.An echocardiogram measured gradient levels of 80 mmhg and indications of pannus formation on the valve.Moderate mitral regurgitation was also noted.No further intervention was prescribed and no other adverse patient effects were reported.

Manufacturer Narrative

Multiple attempts to obtain details regarding this event have been unsuccessful.The date of event and implant date are approximations.The device remains implanted, therefore no product analysis can be performed.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Conclusion: cardiac dysrhythmias (i.E.Electrocardiographic changes) are known potential adverse events per mosaic instructions for use (ifu).These issues can be resolved with the implant of a permanent pacemaker.Based on the received information, it was unclear whether the pacemaker implant was related to any valve issues.With the limited information received, a root cause of the high gradient cannot be determined.Pannus formation has been an inherent risk of surgical valve replacement.

• 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 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: 4786421
• MDR Text Key: 5853903
• Report Number: 2025587-2015-00578
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305
• Device Catalogue Number: 305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• 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: 00072 YR
• Patient Weight: 93