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

Model Number 700FC23

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

Patient Problems Mitral Regurgitation (1964); No Information (3190)

Event Date 09/06/2019

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 immediately post implant of this 23mm mitral annuloplasty band, it was explanted and replaced with an unknown device.The reason for replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the reason for the explant and replacement was severe residual regurgitation.The annuloplasty band was replaced with a non-medtronic mechanical valve.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: 9111540
• MDR Text Key: 159852882
• Report Number: 2025587-2019-02899
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182417
• UDI-Public: 00643169182417
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 700FC23
• Device Catalogue Number: 700FC23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 90