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

Model Number 310C27

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Regurgitation (2023); Tricuspid Regurgitation (2112); No Information (3190)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 2 years 8 months post implant of this bioprosthetic valve, the device was replaced valve-in-valve with a transcatheter pulmonary valve (tpv) in the tricuspid position for unknown reasons.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the reason for the valve-in-valve procedure was due to severe tricuspid and pulmonary regurgitation.No additional adverse patient effects were reported.  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 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: 7142400
• MDR Text Key: 95624585
• Report Number: 2025587-2017-02545
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001633
• UDI-Public: 00643169001633
• 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: 02/14/2018

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: 10/15/2019
• Device Model Number: 310C27
• Device Catalogue Number: 310C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/14/2018
• Date Device Manufactured: 11/24/2014
• 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: 58 YR
• Patient Weight: 54