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

Model Number AF-834

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

Due to the limited information on the patient's outcome and the link with the device, the event is being reported in a conservative manner.The manufacturer is following up to obtain further information on the event.Device location not presently known.

Event Description

An annuloflex af-834 was implanted and explanted in mitral position intra-operatively on (b)(6) 2018.No other information is currently available.

Manufacturer Narrative

Based on the additional information received by the hospital, the event is not attributable to the device, but it is a case of a mitral repair converted to a mitral valve replacement.Therefore, no further investigation is warranted at this time.

Event Description

An annuloflex af-834 was implanted and explanted in mitral position intra-operatively on (b)(6) 2018.The site reported that the repair was ultimately converted with a full mitral valve replacement.The hospital communicated that the device was not perceived as faulty.The patient's outcome after the surgery is good.

• Brand Name: ANNULOFLEX MITRAL ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8104378
• MDR Text Key: 128383607
• Report Number: 3005687633-2018-00219
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057013644
• UDI-Public: (01)08022057013644(240)AF-834(17)220807
• Combination Product (y/n): N
• PMA/PMN Number: K023185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: AF-834
• Device Catalogue Number: AF-834
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR