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

Model Number	AF-832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to limited information, this event is being reported in a conservative manner.The manufacturer is in the process of contacting the physician to obtain further information on this event and if the device has been explanted to date.Not yet determined if device available.
Event or Problem Description
On (b)(6) 2017 the manufacturer received notification from patient tracking of an annuloflex mitral annuloplasty ring that was implanted on (b)(6) 2012 and now will be explanted/replaced by a valve.
Additional Manufacturer Narrative
The manufacturer attempted to follow up with the implanting surgeon but was unable to obtain further information.As the manufacturer was unable to follow up, the device was not returned for analysis and no device investigation can be performed at this time.Based on clinical experience, the explant of an annuloplasty ring and subsequent replacement by a mitral valve prosthesis most commonly indicates explant due to patient conditions, in which the ring ceases to provide adequate repair for the patient, thus requiring a complete valve replacement.As such, no investigation is warranted based on the information available.If additional information is obtained in the future, appropriate investigative actions will be taken.

• 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: 6676037
• Report Number: 3005687633-2017-00068
• Device Sequence Number: 72065
• Product Code: KRH
• UDI-Device Identifier: 08022057013637
• UDI-Public: (01)08022057013637(240)AF-832(17)170604
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 06/04/2017
• Device Model Number: AF-832
• Device Catalogue Number: AF-832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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: 54 YR