MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION VALVE HANCOCK II MITRAL 31MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510-31H

Device Problem Insufficient Information (3190)

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

Event Date 06/14/2019

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 18 years and 7 months post implant of this mitral bioprosthetic valve, the valve was explanted and replaced with a bioprosthetic valve of a different model.The reason for the explant was reported as the valve "wore out", along with stenosis and severe mitral regurgitation.No additional adverse patient effects were reported. .

• Brand Name: VALVE HANCOCK II MITRAL 31MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 8744004
• MDR Text Key: 149496597
• Report Number: 2025587-2019-02079
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510-31H
• Device Catalogue Number: T510-31H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2019
• 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: 63 YR