MAUDE Adverse Event Report: SORIN GROUP ITALIA CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING

Model Number	ANNULOFLEX SIZE 36
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is attempting to obtain the information and the testing methods will be determined upon receipt of additional information.Information regarding the reason for explant and the availability of the device is not available at this time.The manufacturer is reporting this event in a conservative manner.
Event or Problem Description
The manufacturer received a patient tracking form on 11-oct-2016 of the following: a carbomedics annuloflex sn# (b)(4) was removed from the patient on (b)(6) 2016 at (b)(6) and the date of implant is unknown.
Additional Manufacturer Narrative
It was confirmed on (b)(6) 2016 from follow-up that this was not an issue with the ring but a case in which the physician tried to repair the valve but based on the patient¿s condition ended up having to replace the entire valve with a edwards tissue prosthesis.Therefore this is not a complaint on the repair ring as it was simply an issue of patient anatomy and should not have been initially reported.

• Brand Name: CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING
• Common Device Name: ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA; strada per crescentino, sn; saluggia,
• MDR Report Key: 6142447
• Report Number: 3005687633-2016-00022
• Device Sequence Number: 18921961
• Product Code: KRH
• UDI-Device Identifier: 08022057013651
• UDI-Public: (01)08022057013651(240)AF-836(17)200524
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: ANNULOFLEX SIZE 36
• Device Catalogue Number: AF-836
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 05/10/2017
• 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: 65 YR