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

Model Number	AF-836
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is attempting to obtain additional information about this event.When further information is received, appropriate investigative actions will be taken.Device disposition not presently known.
Event or Problem Description
The manufacturer was notified via patient tracking that an annuloflex ring, af-836, was implanted and explanted on the same day.The device was replaced with a smaller annuloflex ring, af-834.No other information was provided.
Additional Manufacturer Narrative
The manufacturer was unable to obtain additional information about this event.Based on the event information provided, the device was explanted intraoperatively, and replaced with the same device in a different size.As such, it can reasonably be concluded that the event was attributable to mis-sizing, and no further investigation is warranted at this time.Device not available, unable to followup.

• 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, vc 13040 ; IT 13040
• MDR Report Key: 7307219
• Report Number: 3005687633-2018-00119
• Device Sequence Number: 1343142
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)211122
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: Physician
• Device Expiration Date: 11/22/2021
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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: 23 YR