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

Model Number 305U225

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Atrial Tachycardia (1731); Bradycardia (1751); Cardiac Arrest (1762); Dyspnea (1816); Dizziness (2194); Complete Heart Block (2627)

Event Date 10/22/2014

Event Type  Injury  

Event Description

Medtronic received information that the day after implant of this bioprosthetic aortic heart valve, the patient exhibited dizziness and dyspnea due to transient third-degree heart block with pauses and sinus bradycardia.Temporary pacing support was provided.Three days post-implant, the patient exhibited atrial fibrillation, and was treated with medication which resulted in conversion to a sinus rhythm.Six days post-implant, the patient was symptomatic with observations of 2:1 atrio-ventricular heart block with bradycardia and complete heart block.A permanent pacemaker was implanted the following day.The patient then exhibited atrial tachycardia with ventricular response, which was successfully treated with medication.No subsequent adverse patient effects were reported.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.(b)(4).

Manufacturer Narrative

Conduction disturbances such as (i.E.Atrial fibrillation, bradycardia and heart block) are known potential adverse effects and can be resolved with medical treatment or the implant of a permanent pacemaker.A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.The device remains implanted.

Manufacturer Narrative

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

• 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: 4242968
• MDR Text Key: 5018260
• Report Number: 2025587-2014-00876
• 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: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2014

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 Expiration Date: 05/14/2019
• Device Model Number: 305U225
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; 12/12/2014
• Supplement Dates FDA Received: 01/03/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2014
• 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: 00079 YR