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

Model Number	700FF35
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	08/14/2019
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 35mm mitral annuloplasty band, it was explanted and replaced with a 39mm annuloplasty band of the same model.The reason for replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that the 35mm band was too small for the patient's annulus, subsequently resulting in systolic anterior motion of the mitral valve.There was no allegation against the 35mm band itself.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8992648
• Report Number: 2025587-2019-02785
• Device Sequence Number: 3380954
• Product Code: KRH
• UDI-Device Identifier: 00643169182523
• UDI-Public: 00643169182523
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 04/02/2024
• Device Model Number: 700FF35
• Device Catalogue Number: 700FF35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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: 68 YR
• Patient Weight: 64