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

Model Number	AF-828
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time the manufacturer has no additional event information or information regarding the device location, cause of the event, impact to the patient etc.If additional information is received the manufacturer will perform investigations accordingly.Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2019 a patient was intended to recieve a annuloflex af-828 mechanical mitral repair ring.The manufacturer was notified that the device was implanted and explanted on the same day.No further information was received.
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 has made several attempts to follow-up for further information but no further information has been received.At this time because the device disposition is unknown no further investigations beyond the review of the device history records are possible.The device history record review showed the device satisfied all material, visual and performance standards required at the time of manufacture and release, however, because no further investigations are possible the root cause of the reported event cannot be determined at this time.If further information is received the manufacturer will reassess the investigation at that time.Fields changed: b4, g4, g7, h2, h6.

• 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
• MDR Report Key: 9547449
• Report Number: 3005687633-2020-00097
• Device Sequence Number: 14024206
• Product Code: KRH
• UDI-Device Identifier: 08022057013613
• UDI-Public: (01)08022057013613(240)AF-828(17)230416
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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: 04/16/2023
• Device Model Number: AF-828
• Device Catalogue Number: AF-828
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 05/25/2020
• 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
• Patient Age: 75 YR