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

Model Number 305U223

Device Problems Perivalvular Leak (1457); Device Appears to Trigger Rejection (1524)

Patient Problems Host-Tissue Reaction (1297); Insufficiency, Valvular (1926); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: 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 and 3 months post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a 21mm non-medtronic bioprosthetic valve.The reason for replacement was reported as severe central aortic valve insufficiency and a severe paravalvular leak observed under the right coronary artery and under the left main coronary artery.It was reported the patient was in class iii heart failure prior to the re-do replacement.During the explant procedure, it was observed that the left main coronary artery was "largely obstructed by pannus", and that there was fibrous tissue around the pledgets of the bioprosthesis.At the end of the procedure, an intra-aortic balloon pump was implanted percutaneously in the left common femoral artery and the patient was reported to be in stable condition.No additional adverse patient effects were reported.

• 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: 10645473
• MDR Text Key: 210377854
• Report Number: 2025587-2020-03049
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001664
• UDI-Public: 00643169001664
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Date Device Manufactured: 02/24/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 85