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

Model Number	AF-836
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is in the process of obtaining additional information about this event.Device disposition not presently known.
Event or Problem Description
It was reported that an annuloflex, size 36, was implanted and "removed" on (b)(6) 2018.No other information was provided.
Additional Manufacturer Narrative
Based on the information received, the implanted ring was too small.The event is attributable to user error, and no further investigation is warranted.Updated fields: not required for investigation.
Event or Problem Description
An annuloflex size 36 was implanted.However, upon testing the repair there was mitral regurgitation and the ring was found to be too small, so the surgeon explanted the device and placed an alfieri stitch.Since a larger ring was not available, no ring was implanted.Tee showed trace to no mr, no ms, normal wall motion, normal ef.All findings were 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, vc 13040 ; IT 13040
• MDR Report Key: 7695120
• Report Number: 3005687633-2018-00175
• Device Sequence Number: 996082
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)AA12
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/30/2018

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: 12/09/2019
• Device Model Number: AF-836
• Device Catalogue Number: AF-836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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: 67 YR