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

Model Number	AF-832
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Stenosis (1965); No Information (3190)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information on this event through the device tracking department.Based on the information reported in the patient implant form, an annuloflex size 32 implanted on (b)(6) 2008 was explanted on (b)(6) 2020.No further information is presently available.
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.The manufacturer made several attempts to follow-up for further information related to the specific event details and no further information was received.At this time since information regarding the device is not available no further investigations can be performed.The case will be closed at this time as no further investigation is possible.However, should additional information be provided, the manufacturer will re-assess the event and take further investigative action as applicable.The root cause is thus deemed to be cause not established.
Event or Problem Description
The manufacturer received information on this event through the device tracking department.Based on the information reported in the patient implant form, an annuloflex size 32 implanted on (b)(6) 2008 was explanted on (b)(6) 2020.The manufacturer received additional information regarding this event, identifying that the diagnosis was of severe mitral valve stenosis with a gradient of about 14 in previous mitral valve repair.The patient developed shortness of breath.The explanted mitral valve replacement with a #29 carbomedics valve through median sternotomy.The findings of the procedure were severely stenotic mitral valve with ring in place requiring a replacement.The procedure was completed uneventfully.No further information on the device disposition after the explant was provided.
Additional Manufacturer Narrative
Based on the available information, there is no evidence of a device malfunction which could have caused or contributed to the reported event.As reported, the diagnosis was of mitral stenosis of the valve.Thus, the root cause can be reasonably attributed to patient's factor for which a repair was no longer sufficient and warranted a full valve replacement.As such, no further investigation is warranted and the case is considered closed at this time.

• Brand Name: CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10544374
• Report Number: 1718850-2020-01138
• Device Sequence Number: 3569214
• Product Code: KRH
• UDI-Device Identifier: 08022057013637
• UDI-Public: (01)08022057013637(240)AF-832(17)130426
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2020
• Report Date (Section F): 08/17/2020

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: 04/26/2013
• Device Model Number: AF-832
• Device Catalogue Number: AF-832
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/02/2020
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/17/2020; 08/17/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/28/2020; 12/02/2020
• 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