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

Model Number 305C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The device was replaced valve-in-valve and remains implanted in the patient; the device will not be returned for analysis.Without the return of the valve for analysis, a root cause of the stenosis and regurgitation cannot be determined.

Event Description

Medtronic received information that four years, five months post implant of this bioprosthetic valve implanted in the pulmonary position, the device was replace valve-in-valve with a medtronic transcatheter pulmonary valve (tpv) due to stenosis and regurgitation.No further adverse patient effects were reported.

Manufacturer Narrative

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.

• 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: 5995692
• MDR Text Key: 56331806
• Report Number: 2025587-2016-01561
• 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: 09/20/2016

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: 11/03/2016
• Device Model Number: 305C
• Device Catalogue Number: 305C221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: 09/20/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2012
• 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: 15 YR
• Patient Weight: 55