MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION MOSAIC; HEART-VALVE, REPLACEMENT

Model Number 305C21

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.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 from the patient that 15 years and 2 months post implant of this aortic bioprosthetic valve, they are being considered for valve-in-valve replacement due to "mis-match" and increased gradients of 35 mmhg.Ultimately 15 years and 10 months post implant a transcatheter valve was implanted valve-in-valve.Stenosis was reported as the reason for replacement.No additional adverse patient effects were reported. .

• Brand Name: MOSAIC
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 10257953
• MDR Text Key: 198340873
• Report Number: 2025587-2020-02203
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00721902694738
• UDI-Public: 00721902694738
• 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
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305C21
• Device Catalogue Number: 305C21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• 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: 84 YR