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

Model Number 700FF29

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/05/2019

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 29mm mitral annuloplasty ring, the ring was explanted and replaced with a 27mm ring of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the 29mm annuloplasty ring was implanted in the tricuspid position and the 27mm ring was implanted in the mitral position.Both devices remain implanted and active.There was no allegation against either device's identity, quality, durability, reliability, safety, effectiveness, or performance.Coding if information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8731882
• MDR Text Key: 149110598
• Report Number: 2025587-2019-02034
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182424
• UDI-Public: 00643169182424
• Combination Product (y/n): N
• PMA/PMN Number: K052565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700FF29
• Device Catalogue Number: 700FF29
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR