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

Model Number	AF-8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition not presently known.
Event or Problem Description
An annuloflex mitral annuloplasty ring was implanted and explanted on (b)(6) 2018.No other information was provided.
Additional Manufacturer Narrative
Correction: conclusion codes updated.Codes inadvertently omitted from last report.The manufacturer was unable to obtain additional information about this event.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the results of the document review performed, no manufacturing deficiency was identified.As no details about the device explant or replacement are known, the root cause of the event cannot be determined and it is not clear whether an event has occurred.The event was reported in a conservative manner due to limited information.

• 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: 7383008
• Report Number: 3005687633-2018-00131
• Device Sequence Number: 13484791
• Product Code: KRH
• UDI-Device Identifier: 08022057013620
• UDI-Public: (01)08022057013620(240)AF-830(17)210816
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/08/2018

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: 08/16/2021
• Device Model Number: AF-8
• Device Catalogue Number: AF-830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018; 06/08/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/08/2018; 06/08/2018
• 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: 63 YR