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

Model Number	AF-834
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Disposition not presently known.
Event or Problem Description
An annuloflex af-834 mitral annuloplasty ring was implanted and explanted on (b)(6) 2019.The device was replaced with another annuloflex ring of the same size.
Additional Manufacturer Narrative
It was reported that the annuloplasty ring was explanted due to a failed initial attempt to repair the mitral valve.This is a procedure-related event, and is unrelated to the device.It should be noted that the subsequent complications (hemodynamic instability requiring coronary artery bypass graft and subsequent implant of an intra-aortic balloon pump) can also be attributed to the procedure (specifically, the ligation of the circumflex coronary).Based on the information provided, no device issue has been identified.
Event or Problem Description
A mitral valve repair was performed using an annuloflex af-834 annuloplasty ring.Saline testing following the initial attempt to repair the valve revealed that the valve was coapting too far anteriorly.The annuloplasty ring was therefore removed, and a new annuloflex af-824 was implanted.The second repair was successful.The mitral valve was functioning normally with trace insufficiency, and no aortic insufficiency was observed.There was no systolic anterior motion.However, after weaning from bypass, the patient deteriorated hemodynamically due to ligation of the circumflex coronary artery.The procedure was converted to sternotomy and cabg was performed.An iabp was ultimately implanted and the patient was transported to intensive care in critical condition.

• 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: 8375791
• Report Number: 3005687633-2019-00150
• Device Sequence Number: 16695044
• Product Code: KRH
• UDI-Device Identifier: 08022057013644
• UDI-Public: (01)08022057013644(240)AF-834(17)230821
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K023185
• 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): 04/11/2019

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: 08/21/2023
• Device Model Number: AF-834
• Device Catalogue Number: AF-834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: 67 YR