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

Model Number	AF-834
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, an annuloflex annuloplastry ring af-834 was implanted and explanted on the same day on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
Event or Problem Description
See initial report.
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.Since the device was not returned to the manufacturer, no further investigation on the device could be possible.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.The manufacturer attempted to retrieve additional information on the event, but no further information has been provided to date.Should the manufacturer receive additional information in the future, a follow up report will be submitted.

• Brand Name: CARBOMEDICS ANNULOFLEX ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino; saluggia, vercelli
• MDR Report Key: 11793579
• Report Number: 1718850-2021-01072
• Device Sequence Number: 19800688
• Product Code: KRH
• UDI-Device Identifier: 08022057013644
• UDI-Public: (01)08022057013644(240)AF-834(17)240818
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021
• Report Date (Section F): 04/09/2021

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: 08/18/2024
• Device Model Number: AF-834
• Device Catalogue Number: AF-834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2021
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 69 YR