MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ANNULOFLEX MITRAL ANNULOPLASTY RING

Model Number	AF-834
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the limited information on the patient's outcome and the link with the device, the event is being reported in a conservative manner.The manufacturer is following up to obtain further information on the event.Device location not presently known.
Event or Problem Description
An annuloflex af-834 was implanted and explanted in mitral position intra-operatively on (b)(6) 2018.No other information is currently available.
Additional Manufacturer Narrative
Based on the additional information received by the hospital, the event is not attributable to the device, but it is a case of a mitral repair converted to a mitral valve replacement.Therefore, no further investigation is warranted at this time.
Event or Problem Description
An annuloflex af-834 was implanted and explanted in mitral position intra-operatively on (b)(6) 2018.The site reported that the repair was ultimately converted with a full mitral valve replacement.The hospital communicated that the device was not perceived as faulty.The patient's outcome after the surgery is good.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8104378
• Report Number: 3005687633-2018-00219
• Device Sequence Number: 19165687
• Product Code: KRH
• UDI-Device Identifier: 08022057013644
• UDI-Public: (01)08022057013644(240)AF-834(17)220807
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 08/07/2022
• Device Model Number: AF-834
• Device Catalogue Number: AF-834
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: 77 YR