MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number 700FC25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/24/2019

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 this 25mm mitral annuloplasty band was implanted and explanted during the same procedure for mitral regurgitation.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the mitral annuloplasty band was replaced with a 31mm non-medtronic bioprosthetic valve.The physician stated that there was no malfunction of the annuloplasty band itself.It was also noted that the patient's aortic valve was also replaced during the same procedure.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9156675
• MDR Text Key: 161408060
• Report Number: 2025587-2019-03040
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182400
• UDI-Public: 00643169182400
• Combination Product (y/n): N
• PMA/PMN Number: K052899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: 700FC25
• Device Catalogue Number: 700FC25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR