MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HALL EASY FIT; HEART-VALVE, MECHANICAL

Model Number M7700-27

Device Problem Perivalvular Leak (1457)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/01/1999

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.Date of event is 'year valid'.Only this event was previously reported in regulatory rep #2025587-2020-03089.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately 10 years post implant of this 27mm mechanical mitral valve, the valve had a paravalvular leak.The paravalvular leak was repaired surgically.No additional adverse patient effects were reported.

• Brand Name: HALL EASY FIT
• Type of Device: HEART-VALVE, MECHANICAL
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11302220
• MDR Text Key: 230994375
• Report Number: 2025587-2021-00486
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790018
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M7700-27
• Device Catalogue Number: M7700-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• 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: 51 YR