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

Model Number	700FC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Information (3190)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 this mitral annuloplasty band was implanted and explanted during the same procedure for unknown reasons.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Medtronic received additional information that this mitral annuloplasty band was implanted and explanted due to extensive annular calcification and deteriorated posterior leaflet which lead to an ineffective attempt at valve repair.The band was successfully replaced with a mitral bioprosthetic valve and there were no additional adverse patient effects.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7107692
• Report Number: 9612164-2017-01883
• Device Sequence Number: 1091313
• Product Code: KRH
• UDI-Device Identifier: 00643169182400
• UDI-Public: 00643169182400
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2018

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: 08/31/2021
• Device Model Number: 700FC
• Device Catalogue Number: 700FC25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 01/15/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 12/19/2017; 02/05/2018
• 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: 72 YR
• Patient Weight: 69