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

Model Number	700FF29
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Medtronic received information that immediately post implant of this 29mm tricuspid annuloplasty band, it was explanted and replaced with a 31mm bioprosthetic valve.The reason for replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9166182
• Report Number: 2025587-2019-03071
• Device Sequence Number: 2763152
• Product Code: KRH
• UDI-Device Identifier: 00643169182424
• UDI-Public: 00643169182424
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 700FF29
• Device Catalogue Number: 700FF29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Weight: 59